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Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

Primary Purpose

Chronic Pain

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Hydrocodone ER

Placebo

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring osteoarthritis, low back pain, Moderate to Severe Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient is able to speak English and is willing to provide written informed consent, including a written opioid agreement, to participate in this study.
The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, complete the electronic diary, and return to the clinic for scheduled study visits as specified in this protocol.
Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study, and have a negative pregnancy test at screening.
The patient has pain of at least 3 months' duration associated with osteoarthritis or low back pain.
The patient reports an average pain intensity score, over the prior 24 hours, of 5 or more on the 11-point numerical rating scale.
If the patient is receiving physical therapy, biofeedback therapy, acupuncture therapy, or herbal remedies, these therapies must remain unchanged during the study.
The patient must not participate in other study involving an investigational agent while enrolled into the present study.

Exclusion Criteria:

The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug.
The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse with the exception of nicotine or caffeine.
The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
The patient is taking a total (ie, around-the-clock plus rescue medication) of more than 135 mg/day of oxycodone, or equivalent, during the 14 days prior to screening.
The patient has a history of suicidality.
The patient is expected to have surgery during the study.
The patient's primary painful condition under study is related to any source of chronic pain other than osteoarthritis or low back pain.
The patient is pregnant or lactating.
The patient has active malignancy.
The patient has human immunodeficiency virus (HIV).
In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination and/or clinical laboratory test values.
The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with opioids.
The patient has participated in a study involving an investigational drug in the previous 30 days.
The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.
The patient is involved in active litigation in regard to the pain currently being treated.
The patient has a positive urine drug screen (UDS) that is not medically explainable.
The investigator feels that the patient is not suitable for the study for any reason.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Hydrocodone ER

Arm Description

Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain during the titration period. During the treatment period, participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step-wise, double-blind schedule to tamper off active drug was implemented during the first 2 weeks of the 12-week, double-blind, placebo-controlled treatment period to reduce the risk of withdrawal effects in participants randomly assigned to placebo.

Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain during the titration period. During the 12-week, double-blind, placebo-controlled treatment period, participants randomly assigned to hydrocodone ER were administered tablets every 12 hours at the dosage deemed successful for managing their pain during the titration period.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI)

The primary efficacy variable was the change from baseline to week 12 in the wAPI. The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The Week 12 wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. Negative change from baseline values indicate lessening in pain intensity.

Secondary Outcome Measures

Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason

Percentage of participants who withdrew from the study during the double-blind treatment period. Withdrawal is due to any cause, including lack of efficacy.

Kaplan-Meier Estimates for Time to Discontinuation From the Study

Kaplan-Meier estimates for time to discontinuation from the study (due to any cause) was calculated as the number of days since participants were randomly assigned to study drug treatment, ie, the difference between the date the participants withdrew and the date participants were randomly assigned to study drug treatment. The censoring flag was set to 0 if a participant was withdrawn from study drug treatment early and was set to 1 if the participant completed the 12 week treatment period. Censoring time was calculated as the difference of treatment completion date (ie, date of last study drug administration) and date participant was randomly assigned to study drug treatment.

Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%

The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable.

Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%

Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period

Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period

The WPI was recorded by the patient in the e-diary daily throughout the study, based on the Numeric Rating Scale (NRS-11). Participants were asked to select the number that best described their WPI over the previous 24 hours. Values were averaged for each week. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable.

Clinician Assessment of Patient Function (CAPF) at Week 4

Clinicians assessed participants across 5 dimensions: Patients general activities Patients walking ability Patients ability to work/perform activities of daily living Patients relationships with others Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study.

Clinician Assessment of Patient Function (CAPF) at Week 8

Clinician Assessment of Patient Function (CAPF) at Week 12

Clinician Assessment of Patient Function (CAPF) at Endpoint

Patient Assessment of Function (PAF) at Week 4

The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: ability to go to work ability to perform at work (includes both work outside the home and housework) ability to walk ability to exercise ability to participate in social events ability to have sex ability to enjoy life

Patient Assessment of Function (PAF) at Week 8

Patient Assessment of Function (PAF) at Week 12

Patient Assessment of Function (PAF) at Endpoint

Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period

The CGI-S is a clinician-rated scale that assesses the severity of the patient's pain condition and response to the treatment. Severity of illness, as related to moderate to severe pain, consists of the following 7 categories: 1 normal-shows no sign of illness, 2 borderline ill, 3 mildly (slightly) ill, 4 moderately ill, 5 markedly ill, 6 severely ill, and 7 among the most extremely ill (Guy 1976). The clinician assesses the severity of the patient's condition, based on the clinician's total clinical experience with patients with this condition, in response to treatment. Endpoint values are the last observed postbaseline data.

Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint

SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.

Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period

For pain interference, the BPI-SF used numerical scales to measure how much pain had interfered with 7 daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep in the past 24 hours. The scale used an 11 point Likert scale; range: 0 [does not interfere] to 10 [completely interferes]. BPI pain interference was typically scored as the mean of the 7 interference items. This mean could be used if at least 4 of 7 items had been completed on a given administration.

Participants With Adverse Events

An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period

Data represents participants with potentially clinically significant (PCS) vital sign values. Significance criteria Pulse - high: >=120 and increase of >= 15 beats/minute from baseline Pulse - low: <=50 and decrease of >=15 beats/minute Systolic blood pressure - high: >=180 and increase >=20 mmHg Systolic blood pressure - low: <=90 and decrease >=20 mmHg Diastolic blood pressure - high: >=105 and increase of >=15 mmHg Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg

Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period

Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values. Significance criteria: Blood urea nitrogen: >=10.71 mmol/L Uric acid: M>=625, F>=506 μmol/L Hemoglobin: M<=115, F<=95 g/dL Hematocrit: M<0.37, F<0.32 % Urinalysis: blood (hemoglobin) and total protein: >=2 unit increase from baseline

Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period

The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at weeks 8 and 12 or early termination. The SOWS was a self administered questionnaire used to measure a participant's signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (eg, my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit.

Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period

The COWS was a clinician rated scale used to measure a participant's signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at day 0 and weeks 1, 2, 4, 8, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5. A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows: 0 to 4=normal 5 to 12=mild 13 to 24=moderate 25 to 36=moderately severe >36=severe

Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods

The ABC was a clinician rated scale that consisted of a brief (20 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as one point, and points were added to calculate the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen). The ABC was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination.

Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods

The COMM was a clinician rated scale developed as a brief self report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior. The COMM was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination.

Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters

A 12-lead ECG was conducted at baseline and the last visit during the double-blind treatment period (week 12, or early termination).

Full Information

NCT ID

NCT01240863

First Posted

November 10, 2010

Last Updated

June 2, 2017

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01240863

Brief Title

Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

Official Title

A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to evaluate efficacy of hydrocodone extended-release (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at week 12.

Detailed Description

The study consisted of a screening period of approximately 7 to 14 days, an open label titration period of up to 6 weeks, and a double blind treatment period of 12 weeks. Participants entered the open label titration period and received hydrocodone ER tablets beginning with 15 mg every 12 hours for 3 to 7 days. The objective of the open label titration period was to find the successful dose of hydrocodone ER tablets that produced stable pain relief (defined as an Average Pain Intensity (API) score of 4 or less on the 11-point numerical rating scale for either 3 consecutive days or 3 out of 5 consecutive days while the patient was maintained on the same dose of study drug for up to 7 days). Patients returned to the study center prior to each dose adjustment. Participants who met the criterion of a stabilized dose were randomly assigned into the 12 week, double blind, placebo controlled treatment period on the final day of the open label titration period (baseline visit). Patients began treatment with double blind study drug at the effective dose of hydrocodone ER tablets achieved during the titration period or matching placebo. Rescue medication was permitted in addition to the study drug during the double blind treatment period.

6. Conditions and Keywords

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

Chronic Pain

Keywords

osteoarthritis, low back pain, Moderate to Severe Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

391 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Hydrocodone ER

Arm Type

Experimental

Arm Description

Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain during the titration period. During the 12-week, double-blind, placebo-controlled treatment period, participants randomly assigned to hydrocodone ER were administered tablets every 12 hours at the dosage deemed successful for managing their pain during the titration period.

Intervention Type

Drug

Intervention Name(s)

Hydrocodone ER

Other Intervention Name(s)

CEP-33237, Hydrocodone bitartrate extended-release

Intervention Description

During the open-label, titration period, all participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain. Hydrocodone ER was taken by participants randomized to the hydrocodone ER treatment arm during the double-blind treatment period at the dose level identified during the titration period. Participants were instructed to take tablets with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching the active drug dose identified during the titration period was taken by participants randomized to the placebo treatment arm during the double-blind treatment period. Participants were instructed to take intervention with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.

Primary Outcome Measure Information:

Title

Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI)

Description

Time Frame

Baseline (end of Open-Label Titration Period), Week 12 of Double-blind Treatment Period

Secondary Outcome Measure Information:

Title

Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason

Description

Percentage of participants who withdrew from the study during the double-blind treatment period. Withdrawal is due to any cause, including lack of efficacy.

Time Frame

Day 1 to Week 12 of the double-blind treatment period

Title

Kaplan-Meier Estimates for Time to Discontinuation From the Study

Description

Time Frame

Day 1 to Week 12 of the double-blind treatment period

Title

Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%

Description

Time Frame

Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period

Title

Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%

Description

Time Frame

Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period

Title

Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period

Description

Time Frame

Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period

Title

Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period

Description

Time Frame

Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period

Title

Clinician Assessment of Patient Function (CAPF) at Week 4

Description

Time Frame

Week 4 of the Double-blind Treatment Period

Title

Clinician Assessment of Patient Function (CAPF) at Week 8

Description

Time Frame

Week 8 of the Double-blind Treatment Period

Title

Clinician Assessment of Patient Function (CAPF) at Week 12

Description

Time Frame

Week 12 of the Double-blind Treatment Period

Title

Clinician Assessment of Patient Function (CAPF) at Endpoint

Description

Time Frame

Endpoint of the Double-blind Treatment Period (up to week 12)

Title

Patient Assessment of Function (PAF) at Week 4

Description

Time Frame

Week 4 of the Double-blind Treatment Period

Title

Patient Assessment of Function (PAF) at Week 8

Description

Time Frame

Week 8 of the Double-blind Treatment Period

Title

Patient Assessment of Function (PAF) at Week 12

Description

Time Frame

Week 12 of the Double-blind Treatment Period

Title

Patient Assessment of Function (PAF) at Endpoint

Description

Time Frame

Endpoint of the Double-blind Treatment Period (up to week 12)

Title

Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period

Description

Time Frame

Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period

Title

Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint

Description

Time Frame

Baseline (end of Open-Label Titration Period), Week 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period

Title

Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period

Description

Time Frame

Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period

Title

Participants With Adverse Events

Description

Time Frame

Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period

Title

Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period

Description

Time Frame

Day 1 up to Day 128 in Double-Blind Treatment period

Title

Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period

Description

Time Frame

Day 1 up to Day 128 in Double-Blind Treatment period

Title

Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period

Description

Time Frame

Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period

Title

Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period

Description

Time Frame

Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period

Title

Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods

Description

Time Frame

Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period

Title

Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods

Description

Time Frame

Title

Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters

Description

A 12-lead ECG was conducted at baseline and the last visit during the double-blind treatment period (week 12, or early termination).

Time Frame

Baseline (end of Open-Label Titration Period), Endpoint (last visit up to Week 12) of the Double-blind treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient is able to speak English and is willing to provide written informed consent, including a written opioid agreement, to participate in this study. The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, complete the electronic diary, and return to the clinic for scheduled study visits as specified in this protocol. Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study, and have a negative pregnancy test at screening. The patient has pain of at least 3 months' duration associated with osteoarthritis or low back pain. The patient reports an average pain intensity score, over the prior 24 hours, of 5 or more on the 11-point numerical rating scale. If the patient is receiving physical therapy, biofeedback therapy, acupuncture therapy, or herbal remedies, these therapies must remain unchanged during the study. The patient must not participate in other study involving an investigational agent while enrolled into the present study. Exclusion Criteria: The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug. The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse with the exception of nicotine or caffeine. The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data. The patient is taking a total (ie, around-the-clock plus rescue medication) of more than 135 mg/day of oxycodone, or equivalent, during the 14 days prior to screening. The patient has a history of suicidality. The patient is expected to have surgery during the study. The patient's primary painful condition under study is related to any source of chronic pain other than osteoarthritis or low back pain. The patient is pregnant or lactating. The patient has active malignancy. The patient has human immunodeficiency virus (HIV). In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination and/or clinical laboratory test values. The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with opioids. The patient has participated in a study involving an investigational drug in the previous 30 days. The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug. The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data. The patient is involved in active litigation in regard to the pain currently being treated. The patient has a positive urine drug screen (UDS) that is not medically explainable. The investigator feels that the patient is not suitable for the study for any reason.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sponsor's Medical Expert, MD

Organizational Affiliation

Cephalon

Official's Role

Study Director

Facility Information:

Facility Name

Horizon Research Group LLC

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Radiant Research, Inc.

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85225

Country

United States

Facility Name

Radiant Research, Inc.

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Radiant Research Inc.

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85710

Country

United States

Facility Name

Physician Alliance Research Center

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

Associated Pharmaceutical Research Center, Inc.

City

Buena Park

State/Province

California

ZIP/Postal Code

90620

Country

United States

Facility Name

Providence Clinical Research

City

Burbank

State/Province

California

ZIP/Postal Code

91505

Country

United States

Facility Name

Synergy Clinical Research

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Research Center of Fresno, Inc.

City

Fresno

State/Province

California

ZIP/Postal Code

93726

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

South Orange County Surgical Medical Group

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

Robert M. Karns, MD A Medical Corporation

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Accelovance, Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Radiant Research, Inc.

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95405

Country

United States

Facility Name

Bayview Research Group, LLC

City

Valley Village

State/Province

California

ZIP/Postal Code

91607

Country

United States

Facility Name

Radiant Research, Inc

City

Denver

State/Province

Colorado

ZIP/Postal Code

80239

Country

United States

Facility Name

Clinical Research of West Florida, Inc.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Avail Clinical Research, LLC

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

International Research Associates, LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33183

Country

United States

Facility Name

Compass Research

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Radiant Research, Inc.

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Gold Coast Research LLC

City

Plantation

State/Province

Florida

ZIP/Postal Code

33317

Country

United States

Facility Name

Sarasota Pain Medicine Research LLC

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34238

Country

United States

Facility Name

Clinical Research of West Florida, Inc.

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

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

Better Health Clinical Research, Inc.

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

Millennium Pain Center

City

Bloomington

State/Province

Illinois

ZIP/Postal Code

61701

Country

United States

Facility Name

Medex Healthcare Research, Inc.

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60603

Country

United States

Facility Name

Rehabilitation Associates of Indiana

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46250

Country

United States

Facility Name

International Clinical Research, Inc.

City

Leawood

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

Community Research

City

Crestview

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

The Pain Treatment Center of the Bluegrass

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Horizon Research Group, LLC

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

WK River Cities Clinical Research Center

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105

Country

United States

Facility Name

MidAtlantic Pain Medicine Center

City

Pikesville

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

Beacon Clinical Research, LLC

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

02301

Country

United States

Facility Name

HealthCare Research

City

Florissant

State/Province

Missouri

ZIP/Postal Code

63031

Country

United States

Facility Name

Medex Healthcare Research Inc.

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Sundance Clinical Research, LLC

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Meridian Clinical Research

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Clinical Research Center of Nevada

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

Facility Name

Advanced Pain Consultants

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Upstate Clinical Research Associates

City

Williamsville

State/Province

New York

ZIP/Postal Code

14221

Country

United States

Facility Name

Wake Research Associates

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Radiant Research, Inc

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Sterling Research Group, Ltd.

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Community Research, Inc

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

Facility Name

Community Research, Inc

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Rapid Medical Research

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Columbus Clinical Research

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

SP Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Pain Research of Oregon

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Summit Research Network Inc.

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Brandywine Clinical Research

City

Downingtown

State/Province

Pennsylvania

ZIP/Postal Code

19335

Country

United States

Facility Name

Tipton Medical and Diagnostic Center

City

Tipton

State/Province

Pennsylvania

ZIP/Postal Code

16684

Country

United States

Facility Name

AMH Feasterville Family Health Care Center

City

Trevose

State/Province

Pennsylvania

ZIP/Postal Code

19053

Country

United States

Facility Name

Clinical Research Center of Reading

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Omega Medical Research

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Radiant Research Inc.

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Greenville Pharmaceutical Research

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Radiant Research, Inc

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Trident Institute of Medical Research, LLC

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

South Carolina Pharmaceutical Research

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

KRK Medical Research

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Radiant Research Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Renaissance Clinical Research & Hypertension of Texas, PLLC

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Medstar Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77083

Country

United States

Facility Name

Benchmark Research

City

San Angelo

State/Province

Texas

ZIP/Postal Code

76904

Country

United States

Facility Name

DCT-Sugarland, LLC

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77478

Country

United States

Facility Name

Hillcrest Family Health Centers

City

Waco

State/Province

Texas

ZIP/Postal Code

76710

Country

United States

Facility Name

Aspen Clinical Research, LLC

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

Facility Name

Lifetree Clinical Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

12. IPD Sharing Statement

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Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

Chronic Pain

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