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PF-06372865 In Subjects With Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-06372865
Placebo
Naproxen
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

  • Agave Clinical Research, LLC
  • Arizona Research Center, Inc.
  • Global Research
  • Neuro-Pain Medical Center
  • Providence Clinical Research
  • Elite Clinical Trials, Incorporate
  • Stamford Therapeutics Consortium
  • Avail Clinical Research, LLC
  • S&W Clinical Research
  • Florida Research Network, LLC
  • Broward Research Group
  • Jacksonville Center for Clinical Research
  • Compass Research, LLC
  • Pines Clinical Research Inc.
  • Accord Clinical Research, LLC
  • Arthritis & Rheumatic Care Center
  • Miami Research Associates
  • Better Health Clinical Research, Inc.
  • River Birch Research Alliance, LLC
  • Family Medicine center
  • Columbus Regional Research Institute
  • Drug Studies America
  • Better Health Clinical Research, Inc./Georgia Pain & Spine Care, Inc.
  • Better Health Clinical Research, Inc.
  • Southeast Regional Research Group
  • North Georgia Clinical Research
  • North Georgia Internal medicine
  • Chicago Anesthesia Associates
  • Centex Studies, Inc
  • Boston Clinical Trials
  • ActivMed Practices & Research, Inc.
  • CRC of Jackson
  • Physician's Surgery Center
  • Drug Trials America
  • AAIR Research Center
  • Wake Internal Medicine Consultants, Inc.
  • Wake Research Associates, LLC
  • The Center for Clinical Research
  • Summit Research Network (Oregon), Inc.
  • Altoona Center for Clinical Research
  • Omega Medical Research
  • Clinical Trial Network
  • Lee Medical Associates, PA
  • Progressive Clinical Research
  • National Clinical Research - Norfolk, Inc.
  • Summit Research Network (Seattle) LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

PF-06372865

Placebo

Naproxen

Arm Description

Daily BID dosing for 4 weeks

Daily BID dosing for 4 weeks

Daily BID dosing for 4 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Number of Participants With Laboratory Abnormalities
Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [<] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (<0.6*LLN, greater than [>] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (<0.9*LLN, >1.1*ULN); platelets (<0.5*LLN>, >1.75*ULN); neutrophils, lymphocytes(<0.8*LLN, >1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); total protein, albumin (<0.8*LLN, >1.2*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN, >1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN, >1.1*ULN); urine pH (<4.5, >8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [>=] 1) in urine dipstick test; urine RBC, WBC (>=20); hyaline casts (>1), bacteria (>20).
Number of Participants With Vital Sign Abnormalities
Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.
Number of Participants With Electrocardiogram (ECG) Abnormalities
Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum of >=25 percent (%) increase from baseline (IFB) value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior =3 ("Yes" on "preparatory acts or behavior"), suicidal ideation =4 ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit
PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.

Secondary Outcome Measures

Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4
Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.
Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4
Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.
Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline
Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at >=30 percent and >=50 percent reduced from baseline were reported.
Number of Participants Withdrawn Due to Lack of Efficacy
Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.
Time to Withdrawal Due to Lack of Efficacy
Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as "Insufficient Clinical Response". Time to withdrawal was calculated as Date of withdrawal - Date of Randomization.
Number of Participants Using Rescue Medication
Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.
Number of Days Participants Used the Rescue Medication
The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.
Amount of Rescue Medication Used by the Participants
The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3
Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4
Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4
This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.
Chronic Low Back Pain (CLBP) Responder Index Analysis
Participants were successful responders if they had any of the following: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.
Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4
Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.
Patient Global Impression of Change (PGI-C) Score
PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.
Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4
Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.
Plasma Concentration of PF-06372865
Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was <0.0100 nanogram per milliliter (ng/mL).
Plasma Concentration of Naproxen
Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL.

Full Information

First Posted
October 9, 2014
Last Updated
November 4, 2016
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02262754
Brief Title
PF-06372865 In Subjects With Chronic Low Back Pain
Official Title
A Randomized, Double Blind, Placebo- And Active-controlled, 4 Week, Multi-center, Parallel Group Study Assessing The Analgesic Effect, Safety And Tolerability Of Pf-06372865 In Subjects With Chronic Low Back Pain Using Naproxen As Positive Control
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
PF-06372865 In Subjects With Chronic Low Back Pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06372865
Arm Type
Experimental
Arm Description
Daily BID dosing for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily BID dosing for 4 weeks
Arm Title
Naproxen
Arm Type
Active Comparator
Arm Description
Daily BID dosing for 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-06372865
Intervention Description
Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for PF-06372865 and placebo for naproxen daily
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
500 mg BID for 4 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4
Description
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
Time Frame
Baseline, Week 4
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame
Baseline up to 28 days after the last dose of study treatment (Day 56)
Title
Number of Participants With Laboratory Abnormalities
Description
Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [<] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (<0.6*LLN, greater than [>] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (<0.9*LLN, >1.1*ULN); platelets (<0.5*LLN>, >1.75*ULN); neutrophils, lymphocytes(<0.8*LLN, >1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); total protein, albumin (<0.8*LLN, >1.2*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN, >1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN, >1.1*ULN); urine pH (<4.5, >8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [>=] 1) in urine dipstick test; urine RBC, WBC (>=20); hyaline casts (>1), bacteria (>20).
Time Frame
Baseline up to 28 days after the last dose of study treatment (Day 56)
Title
Number of Participants With Vital Sign Abnormalities
Description
Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.
Time Frame
Baseline up to Follow-up (44 days)
Title
Number of Participants With Electrocardiogram (ECG) Abnormalities
Description
Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum of >=25 percent (%) increase from baseline (IFB) value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).
Time Frame
Baseline up to Follow-up (44 days)
Title
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior =3 ("Yes" on "preparatory acts or behavior"), suicidal ideation =4 ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Time Frame
Screening, Baseline, Week 1, 2, 3, 4
Title
Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit
Description
PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.
Time Frame
End of treatment (Day 30), follow-up (Day 44)
Secondary Outcome Measure Information:
Title
Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4
Description
Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.
Time Frame
Baseline, Week 1, 2, 3, 4
Title
Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4
Description
Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.
Time Frame
Baseline, Week 1, 2, 3, 4
Title
Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline
Description
Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at >=30 percent and >=50 percent reduced from baseline were reported.
Time Frame
Baseline up to Week 4
Title
Number of Participants Withdrawn Due to Lack of Efficacy
Description
Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.
Time Frame
Baseline up to Week 4
Title
Time to Withdrawal Due to Lack of Efficacy
Description
Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as "Insufficient Clinical Response". Time to withdrawal was calculated as Date of withdrawal - Date of Randomization.
Time Frame
Baseline up to Week 4
Title
Number of Participants Using Rescue Medication
Description
Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.
Time Frame
Week 1, 2, 3, 4
Title
Number of Days Participants Used the Rescue Medication
Description
The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.
Time Frame
Week 1, 2, 3, 4
Title
Amount of Rescue Medication Used by the Participants
Description
The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.
Time Frame
Week 1, 2, 3, 4
Title
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3
Description
Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.
Time Frame
Baseline, Week 1, 2, 3
Title
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4
Description
Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.
Time Frame
Baseline, Week 4
Title
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4
Description
This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.
Time Frame
Baseline, Week 2, Week 4
Title
Chronic Low Back Pain (CLBP) Responder Index Analysis
Description
Participants were successful responders if they had any of the following: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.
Time Frame
Week 1, 2, 3, 4
Title
Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4
Description
Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.
Time Frame
Baseline, Week 1, 2, 3, 4
Title
Patient Global Impression of Change (PGI-C) Score
Description
PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.
Time Frame
Week 1, 2, 3, 4
Title
Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4
Description
Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.
Time Frame
Week 4
Title
Plasma Concentration of PF-06372865
Description
Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was <0.0100 nanogram per milliliter (ng/mL).
Time Frame
Baseline, Week 1, 2, 3, 4
Title
Plasma Concentration of Naproxen
Description
Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL.
Time Frame
Baseline, Week 1, 2, 3, 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: -
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
Agave Clinical Research, LLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Arizona Research Center, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Global Research
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Providence Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Elite Clinical Trials, Incorporate
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
S&W Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Florida Research Network, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Broward Research Group
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Pines Clinical Research Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Accord Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Arthritis & Rheumatic Care Center
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Better Health Clinical Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30344
Country
United States
Facility Name
River Birch Research Alliance, LLC
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Family Medicine center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Better Health Clinical Research, Inc./Georgia Pain & Spine Care, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Better Health Clinical Research, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Southeast Regional Research Group
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
North Georgia Internal medicine
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Chicago Anesthesia Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Centex Studies, Inc
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
ActivMed Practices & Research, Inc.
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
CRC of Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Physician's Surgery Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
AAIR Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Wake Internal Medicine Consultants, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
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
Summit Research Network (Oregon), Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
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
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Lee Medical Associates, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
National Clinical Research - Norfolk, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Summit Research Network (Seattle) LLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7431006&StudyName=A%20Randomized%2C%20Double%20Blind%2C%20Placebo-%20And%20Active-controlled%2C%204%20Week%2C%20Multi-center%2C%20Parallel%20Group%20Study%20Assessing%20The%20Analgesic%20Effect%2C%20Safety%20And%20Tolerability%20Of%20Pf-06372865%20In%20Subjects%20With%20Chronic%20Low%20Back%20Pain%20Using%20Naproxen%20As%20Positive%20Control
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

PF-06372865 In Subjects With Chronic Low Back Pain

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