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A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

Primary Purpose

Chronic Pain, Low Back Pain, Analgesia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

ALO-02

Placebo

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring oxycodone, naltrexone, chronic pain, low back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Moderate-to-severe chronic low back pain present for at least 3 months.
Require a continuous around-the-clock opioid analgesic for an extended period of time.
Refrain from taking other opioid and non-opioid medications during the study.

Exclusion Criteria:

Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention.
Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain.
Active or ongoing or history of alcohol or drug abuse.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALO-02

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)

Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.

Secondary Outcome Measures

Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).

The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant's score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability.

Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).

Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor).

Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%

Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain.

Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.

Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index

BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index

Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index

Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index

Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)

NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain.

Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period

The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period.

Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment

Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment

The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].

Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline

Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline

The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].

Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period

The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].

Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period

The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].

Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy

If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason.

Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period

If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the [date of event or discontinuation - date of first dose in Double-Blind Period +1].

Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.

COWS Total Score During the Double-Blind Treatment Period

COWS Total Score During the Post-Treatment Period

Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period

The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.

SOWS Total Score During the Double-Blind Treatment Period

SOWS Total Score During the Post-Treatment Period

Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants

RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability.

Change From Screening Period to Randomization Baseline in RMDQ Total Score

Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score

Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score

Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor

Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor

Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor

Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor

Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants

Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.

Satisfaction With Treatment at Randomization Baseline

Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period

Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied).

Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score

SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state.

Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score

Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey

Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey

Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index

The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.

Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS

The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.

Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index

Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health

Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS

Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index

Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS

Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index

Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS

Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment. work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain

Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain

Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain

Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain

Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain

Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.

Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks

Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital

Question 3b: nights stayed in the hospital, if answer to Q3a was yes.

Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.

Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks

Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital

Question 3b: nights stayed in the hospital, if answer to Q3a was yes.

Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments

Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain.

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital

Question 3b: nights stayed in the hospital

Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain

Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain

Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain

Question 3b: nights stayed in the hospital

Mean Oxycodone Average Daily Dose During the Open-Label Titration Period

Mean Oxycodone Duration of Titration During the Open-Label Titration Period

Median Oxycodone Average Daily Dose During the Open-Label Titration Period

Median Oxycodone Duration of Titration During the Open-Label Titration Period

Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period

Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period

Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period

Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period

Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period

Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone.

Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period

Cobs of naltrexone and 6-β-naltrexol

Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period

Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone

Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period

Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol

Full Information

NCT ID

NCT01571362

First Posted

April 3, 2012

Last Updated

February 17, 2017

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01571362

Brief Title

A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

Official Title

A Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Low Back Pain, Analgesia

Keywords

oxycodone, naltrexone, chronic pain, low back pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

410 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALO-02

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ALO-02

Other Intervention Name(s)

oxycodone HCl and naltrexone HCl

Intervention Description

20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral placebo, divided into symmetric doses and administered twice daily

Primary Outcome Measure Information:

Title

Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)

Description

Time Frame

Weeks 11 and 12

Secondary Outcome Measure Information:

Title

Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).

Description

Time Frame

Week 12

Title

Description

Time Frame

Randomization Baseline, Week 12

Title

Description

Time Frame

Weeks 11 and 12

Title

Description

Time Frame

Weeks 11 and 12

Title

Description

Time Frame

Weeks 11 and 12

Title

Description

Time Frame

Weeks 11 and 12

Title

Description

Time Frame

Screening, Week 4, 5, or 6

Title

Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index

Description

Time Frame

Screening, Randomization Baseline

Title

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain

Description

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Time Frame

Weeks 2, 4, 8, and 12

Title

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain

Description

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Time Frame

Weeks 2, 4, 8, and 12

Title

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain

Description

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Time Frame

Weeks 2, 4, 8, and 12

Title

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now

Description

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Time Frame

Weeks 2, 4, 8, and 12

Title

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index

Description

Time Frame

Weeks 2, 4, 8, and 12

Title

Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index

Description

Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

Time Frame

Weeks 2, 4, 8, and 12

Title

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain

Description

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Time Frame

Weeks 2, 4, 8 and 12

Title

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain

Description

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Time Frame

Weeks 2, 4, 8, and 12

Title

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain

Description

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.

Time Frame

Weeks 2, 4, 8, and 12

Title

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now

Description

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.

Time Frame

Weeks 2, 4, 8, and 12

Title

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index

Description

Time Frame

Weeks 2, 4, 8, and 12

Title

Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index

Description

Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

Time Frame

Weeks 2, 4, 8, and 12

Title

Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)

Description

Time Frame

Randomization Baseline, Weeks 11 and 12

Title

Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period

Description

Time Frame

Daily from Day 1 of the Double-Blind Period through Week 12

Title

Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment

Description

Time Frame

Screening, Week 4, 5 or 6

Title

Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment

Description

Time Frame

Screening, Week 4, 5, or 6

Title

Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline

Description

Time Frame

Screening, Randomization Baseline (up to 6 weeks)

Title

Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline

Description

Time Frame

Screening, Randomization Baseline (up to 6 weeks)

Title

Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period

Description

Time Frame

Randomization Baseline, up to Week 12

Title

Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period

Description

Time Frame

Randomization Baseline, up to Week 12

Title

Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy

Description

If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason.

Time Frame

Week 1 up to Week 12

Title

Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period

Description

Time Frame

Week 1 up to Week 12

Title

Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period

Description

Time Frame

Screening, Weeks 1, 2, 3, 4, 5, and 6

Title

COWS Total Score During the Double-Blind Treatment Period

Description

Time Frame

Randomization Baseline, Weeks 1, 2, 4, 8, and 12

Title

COWS Total Score During the Post-Treatment Period

Description

Time Frame

Follow-Up (FU) Weeks 1 and 2

Title

Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category

Description

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

Time Frame

Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)

Title

Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category

Description

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

Time Frame

Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)

Title

Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category

Description

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

Time Frame

Follow-Up Weeks 1 and 2

Title

Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period

Description

Time Frame

Screening, Weeks 1, 2, 3, 4, 5, and 6

Title

SOWS Total Score During the Double-Blind Treatment Period

Description

Time Frame

Randomization Baseline, Weeks 1, 2, 4, 8, and 12

Title

SOWS Total Score During the Post-Treatment Period

Description

Time Frame

Follow-Up Weeks 1 and 2

Title

Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants

Description

Time Frame

Screening, Week 6 (or Early Termination)

Title

Change From Screening Period to Randomization Baseline in RMDQ Total Score

Description

Time Frame

Screening, Randomization Baseline

Title

Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score

Description

Time Frame

Screening, Weeks 2, 4, 8, and 12

Title

Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score

Description

Time Frame

Randomization Baseline, Weeks 2, 4, and 8

Title

Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor

Description

Time Frame

Screening, Randomization Baseline

Title

Description

Time Frame

Screening, Randomization Baseline, or Early Termination

Title

Description

Time Frame

Randomization Baseline, Week 4

Title

Description

Time Frame

Randomization Baseline, Week 8

Title

Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants

Description

Time Frame

End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)

Title

Satisfaction With Treatment at Randomization Baseline

Description

Time Frame

Randomization Baseline

Title

Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period

Description

Time Frame

Week 12 or Early Termination

Title

Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score

Description

Time Frame

Screening, Week 6 (or Early Termination)

Title

Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score

Description

Time Frame

Screening, Randomization Baseline

Title

Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey

Description

Time Frame

Randomization Baseline, Week 12

Title

Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey

Description

Time Frame

Screening, Week 12

Title

Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index

Description

Time Frame

Screening, Week 6 (or Early Termination)

Title

Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS

Description

Time Frame

Screening, Week 6 (or Early Termination)

Title

Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index

Description

Time Frame

Screening, Randomization Baseline

Title

Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS

Description

Time Frame

Screening, Randomization Baseline

Title

Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index

Description

Time Frame

Randomization Baseline, Week 12

Title

Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS

Description

Time Frame

Randomization Baseline, Week 12

Title

Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index

Description

Time Frame

Screening, Week 12

Title

Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS

Description

Time Frame

Screening, Week 12

Title

Description

Time Frame

Screening, Week 6 (or Early Termination)

Title

Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain

Description

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Time Frame

Screening, Randomization Baseline

Title

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain

Description

Time Frame

Randomization Baseline, Weeks 4, 8, and 12

Title

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain

Description

Time Frame

Randomization Baseline, Weeks 4, 8, and 12

Title

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain

Description

Time Frame

Randomization Baseline, Weeks 4, 8, and 12

Title

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain

Description

Time Frame

Randomization Baseline, Weeks 4, 8, and 12

Title

Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain

Description

Time Frame

Screening, Weeks 4, 8, and 12

Title

Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain

Description

Time Frame

Screening, Weeks 4, 8, and 12

Title

Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain

Description

Time Frame

Screening, Weeks 4, 8, and 12

Title

Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain

Description

Time Frame

Screening, Weeks 4, 8, and 12

Title

Description

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Time Frame

Screening, Week 6 (or Early Termination)

Title

Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire

Description

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Time Frame

Screening, Randomization Baseline

Title

Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain

Description

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.

Time Frame

Screening, Randomization Baseline

Title

Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks

Description

Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

Time Frame

Screening, Randomization Baseline

Title

Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital

Description

Question 3b: nights stayed in the hospital, if answer to Q3a was yes.

Time Frame

Screening, Randomization Baseline

Title

Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain

Description

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.

Time Frame

Screening, Week 6 (or Early Termination)

Title

Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks

Description

Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

Time Frame

Screening, Week 6 (or Early Termination)

Title

Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital

Description

Question 3b: nights stayed in the hospital, if answer to Q3a was yes.

Time Frame

Screening, Week 6 (or Early Termination)

Title

Description

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Time Frame

Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)

Title

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain

Description

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain

Time Frame

Randomization Baseline, Weeks 4, 8, and 12

Title

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments

Description

Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain.

Time Frame

Randomization Baseline, Weeks 4, 8, and 12

Title

Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital

Description

Question 3b: nights stayed in the hospital

Time Frame

Randomization Baseline, Weeks 4, 8, and 12

Title

Description

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Time Frame

Screening, Weeks 4, 8, and 12

Title

Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain

Description

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain

Time Frame

Screening, Weeks 4, 8, and 12

Title

Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain

Description

Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

Time Frame

Screening, Weeks 4, 8, and 12

Title

Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain

Description

Question 3b: nights stayed in the hospital

Time Frame

Screening, Weeks 4, 8, and 12

Title

Mean Oxycodone Average Daily Dose During the Open-Label Titration Period

Time Frame

Open-Label Period

Title

Mean Oxycodone Duration of Titration During the Open-Label Titration Period

Time Frame

Open-Label Period

Title

Median Oxycodone Average Daily Dose During the Open-Label Titration Period

Time Frame

Open-Label Period

Title

Median Oxycodone Duration of Titration During the Open-Label Titration Period

Time Frame

Open-Label Period

Title

Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period

Time Frame

Double-Blind Period

Title

Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period

Time Frame

Double-Blind Period

Title

Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period

Time Frame

Double-Blind Period

Title

Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period

Time Frame

Double-Blind Period

Title

Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period

Description

Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone.

Time Frame

Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline

Title

Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period

Description

Cobs of naltrexone and 6-β-naltrexol

Time Frame

Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline

Title

Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period

Description

Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone

Time Frame

Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12

Title

Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period

Description

Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol

Time Frame

Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Moderate-to-severe chronic low back pain present for at least 3 months. Require a continuous around-the-clock opioid analgesic for an extended period of time. Refrain from taking other opioid and non-opioid medications during the study. Exclusion Criteria: Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention. Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain. Active or ongoing or history of alcohol or drug abuse.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Coastal Clinical Research, Inc.

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Dedicated Clinical Research

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85395

Country

United States

Facility Name

Arizona Research Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Premier Research Group Limited

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85027

Country

United States

Facility Name

Anaheim Clinical Trials, LLC

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Med Center

City

Carmichael

State/Province

California

ZIP/Postal Code

95608

Country

United States

Facility Name

Med Investigations, Inc.

City

Fair Oaks

State/Province

California

ZIP/Postal Code

95628

Country

United States

Facility Name

Neuro-Pain Medical Center

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

Pacific Coast Pain Management Center

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92637

Country

United States

Facility Name

Long Beach Center for Clinical Research - previous addresse

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Long Beach Center for Clinical Research

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

Providence Clinical Research

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

Clinicos, LLC

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80904

Country

United States

Facility Name

Lynn Institute of the Rockies Medical Centre

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Avail Clinical Research, LLC

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Ormond Medical Arts pharmaceutical Research Center

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Gold Coast Research, LLC

City

Plantation

State/Province

Florida

ZIP/Postal Code

33317

Country

United States

Facility Name

The Office of Martin E. Hale, MD, PA

City

Plantation

State/Province

Florida

ZIP/Postal Code

33317

Country

United States

Facility Name

Accord Clinical Research, LLC- Duplicate 2

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32129

Country

United States

Facility Name

Accord Clinical Research, LLC- Duplicate

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32129

Country

United States

Facility Name

Clinical Research of West Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

Palm Beach Research Center

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Drug Studies America

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Georgia Institute for Clinical Research, LLC

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

MediSphere Medical Research Center, LLC

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Mid-Atlantic Medical Research - Research Department

City

Hollywood

State/Province

Maryland

ZIP/Postal Code

20636

Country

United States

Facility Name

Clinical Pharmacology Study Group

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Mercy Health Research

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Heartland Clinical Research, Inc.

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Office of Stephen H. Miller, M.D.

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89144

Country

United States

Facility Name

Albuquerque Clinical Trials, Inc.

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Drug Trials America

City

Hartsdale

State/Province

New York

ZIP/Postal Code

10530

Country

United States

Facility Name

Mid Hudson Medical Research, PLLC

City

New Windsor

State/Province

New York

ZIP/Postal Code

12553

Country

United States

Facility Name

Research Across America

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Facility Name

Upstate Clinical Research Associates, LLC

City

Williamsville

State/Province

New York

ZIP/Postal Code

14221

Country

United States

Facility Name

The Center for Clinical Research

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Community Research

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

Facility Name

Columbus Clinical Research

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Lynn Health Science Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Associated Orthopedics

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73119

Country

United States

Facility Name

Hillcrest Clinical Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73119

Country

United States

Facility Name

Allegheny Pain Management, PC

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Omega Medical Research

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Pain Research of Charleston

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

TLM Medical Services

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

FutureSearch Trials of Neurology

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

KRK Medical Research

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

FutureSearch Trials of Dallas, LP

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Quality Research Inc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

Facility Name

Lee Medical Associates

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Progressive Clinical Research, P.A.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31849032

Citation

Gimbel JS, Rauck RL, Bass A, Wilson J, Pixton G, Malhotra B, Wilson G, Wolfram G. Effects of naltrexone exposure observed in two phase three studies with ALO-02, an extended-release oxycodone surrounding sequestered naltrexone. J Opioid Manag. 2019 Sep/Oct;15(5):417-427. doi: 10.5055/jom.2019.0530.

Results Reference

derived

PubMed Identifier

31456431

Citation

Wilson JG, Bass A, Pixton GC, Wolfram G, Rauck RL. Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials. Curr Med Res Opin. 2020 Jan;36(1):91-99. doi: 10.1080/03007995.2019.1661679. Epub 2019 Sep 17.

Results Reference

derived

PubMed Identifier

29041942

Citation

Weil AJ, Masters ET, Barsdorf AI, Bass A, Pixton G, Wilson JG, Wolfram G. Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain. Health Qual Life Outcomes. 2017 Oct 17;15(1):202. doi: 10.1186/s12955-017-0749-y.

Results Reference

derived

PubMed Identifier

25993547

Citation

Rauck RL, Hale ME, Bass A, Bramson C, Pixton G, Wilson JG, Setnik B, Meisner P, Sommerville KW, Malhotra BK, Wolfram G. A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment. Pain. 2015 Sep;156(9):1660-1669. doi: 10.1097/j.pain.0000000000000230.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4531002

Description

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Learn more about this trial

A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

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A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

Chronic Pain, Low Back Pain, Analgesia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial