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RN624 In Adult Patients With Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Naproxen

Placebo

PF-04383119 (RN624)

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female of any race, >18 years of age and have BMI ≤39 kg/m2
Present with duration of chronic low back pain of ≥3 months requiring regular use of analgesic medication (>4 days per week for the past month)
Primary location of low back pain is between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders
Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment at Screening, and completes at least 4 daily pain diaries during the 5 days prior to Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4

Exclusion Criteria:

Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)
History of lumbosacral radiculopathy, spinal stenosis associated with neurological impairment, or neurogenic claudication
Osteoporotic compression fracture within the last 6 months
Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia; Tumors or infections of the spinal cord
Patients receiving acetaminophen only to manage their chronic low back pain
Any uncontrolled or untreated chronic disease

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Naproxen

Placebo

RN624

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6

Secondary Outcome Measures

Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12

Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12

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), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). 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. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12) values minus the baseline value.

Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12

The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions (Q) 1-4 assessed the magnitude of pain (Q1 for worst pain, Q2 for least pain, Q3 for average pain, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain. Question 5 consisted of 7 sub-items (A to G; general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain score, each ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain.

Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less

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), with lower scores indicating less pain. 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. Participants were classified as responders if average LBPI score was 2 or less, and as non-responders if average LBPI score was greater than (>) 2. Participants with average LBPI score of 2 or less were reported.

Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6

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), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). 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 cumulative reduction (as percent) (greater than 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in Average LBPI score from Baseline at Week 6 were reported, participants (%) are reported more than once in categories specified.

Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

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) with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). 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. Participants with >=30% or >=50% reduction from baseline in daily average LBPI score that was maintained for a minimum duration of 4 consecutive days were reported.

Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

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), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). 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 >=30% and >=50% reduction from Baseline in daily average LBPI score were reported.

Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

Time to achieve >=30% or >=50% sustained reduction from baseline (i.e. reduction from baseline in daily average LBPI score that was maintained for a total of 4 consecutive days) was summarized using the Kaplan-Meier estimates of the median time to 30% and 50% response. 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), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). 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.

Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

Total duration of response was defined as the total number of days with >=30% or >=50% reduction from baseline in the daily average LBPI score. 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), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). 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.

Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12

Roland-Morris Disability Questionnaire: low back pain-specific, participant administered questionnaire that assessed how well participants with low back pain were able to function with regard to daily activities. The questionnaire consisted of 24 statements and the participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. The number of statements marked were added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability.

Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12

The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1 to 4 assessed the magnitude of pain (worst, least, average, right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 consisted of 7 sub-items (general activity [GA], mood, walking ability [WA], normal work [NW], relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (did not interfere) to 10 (completely interfere). The response from 7 sub-items of question 5 were averaged to obtain pain interference composite score (CS), range: 0 to 10 (higher score=more interference).

Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12

Patient's global assessment of low back pain scale assessed participants overall impression of disease activity. Participants answered: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded using 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). Participants who reported a change of -4, -3, -2, -1, 0, 1, 2, 3, 4 from Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) score at specified weeks were presented.

Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication

Participants answered: "In all ways, how would you rate your overall response to the study medication today?" Participants responded using a 4-point Likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicated better overall response to the treatment.

Number of Participants Who Discontinued the Study Due to Lack of Efficacy

Time to Discontinuation Due to Lack of Efficacy

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. Median was not estimable if the percentage of participants who discontinued due to lack of efficacy was below 50%.

Number of Participants With Chronic Low Back Pain (CLBP) Response

Participants were considered as CLBP responders if they had achieved a reduction of >=30% in daily average LBPI score from baseline, an increase of >=30% in patient's global assessment of low back pain (disease activity) from baseline, and no worsening (increase) in RMDQ total score from baseline at specified week. Daily average low back pain assessed on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Patient's global assessment of low back pain assessed using 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). RMDQ: low back pain-specific, participant administered questionnaire consisted of 24 statements and participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. Total RMDQ score was calculated as sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability.

Number of Participants Who Used Rescue Medications

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.

Duration of Rescue Medication Use

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The number of days of rescue medication use during the particular week were summarized.

Amount of Rescue Medication Taken

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen (in mg) in each particular week was summarized.

Full Information

NCT ID

NCT00584870

First Posted

December 21, 2007

Last Updated

June 17, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00584870

Brief Title

RN624 In Adult Patients With Chronic Low Back Pain

Official Title

PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND ACTIVE CONTROLLED, MULTICENTER, PARALLEL GROUP PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF RN624 IN ADULT PATIENTS WITH CHRONIC LOW BACK PAIN

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

July 5, 2007 (Actual)

Primary Completion Date

September 2, 2008 (Actual)

Study Completion Date

September 2, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.

6. Conditions and Keywords

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

Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Naproxen

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

RN624

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Naproxen

Intervention Description

Oral naproxen 500 mg twice daily for Weeks 1-12.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.

Intervention Type

Drug

Intervention Name(s)

PF-04383119 (RN624)

Intervention Description

Single IV infusion of 200 micrograms/kg RN624 on Day 1

Primary Outcome Measure Information:

Title

Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6

Description

Time Frame

Baseline, Week 6

Secondary Outcome Measure Information:

Title

Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12

Title

Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12

Description

Time Frame

Baseline, Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12

Title

Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 6, 8, 12

Title

Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less

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), with lower scores indicating less pain. 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. Participants were classified as responders if average LBPI score was 2 or less, and as non-responders if average LBPI score was greater than (>) 2. Participants with average LBPI score of 2 or less were reported.

Time Frame

Week 1, 2, 4, 6, 8, 12

Title

Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6

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), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). 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 cumulative reduction (as percent) (greater than 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in Average LBPI score from Baseline at Week 6 were reported, participants (%) are reported more than once in categories specified.

Time Frame

Week 6

Title

Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

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) with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). 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. Participants with >=30% or >=50% reduction from baseline in daily average LBPI score that was maintained for a minimum duration of 4 consecutive days were reported.

Time Frame

Week 12

Title

Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

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), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). 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 >=30% and >=50% reduction from Baseline in daily average LBPI score were reported.

Time Frame

Weeks 1, 2, 4, 6, 8, 12

Title

Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

Description

Time Frame

Randomization to Last Study Visit (up to 16 weeks)

Title

Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

Description

Time Frame

Week 1 up to Week 12

Title

Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 6, 8, 12

Title

Description

The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1 to 4 assessed the magnitude of pain (worst, least, average, right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 consisted of 7 sub-items (general activity [GA], mood, walking ability [WA], normal work [NW], relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (did not interfere) to 10 (completely interfere). The response from 7 sub-items of question 5 were averaged to obtain pain interference composite score (CS), range: 0 to 10 (higher score=more interference).

Time Frame

Baseline, Week 1, 2, 4, 6, 8, 12

Title

Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12

Description

Time Frame

Week 1, 2, 4, 6, 8, 12

Title

Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication

Description

Time Frame

Week 1, 2, 4, 6, 8, 12

Title

Number of Participants Who Discontinued the Study Due to Lack of Efficacy

Time Frame

Baseline up to Week 12

Title

Time to Discontinuation Due to Lack of Efficacy

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants With Chronic Low Back Pain (CLBP) Response

Description

Time Frame

Weeks 1, 2, 4, 6, 8, 12

Title

Number of Participants Who Used Rescue Medications

Description

Time Frame

Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Title

Duration of Rescue Medication Use

Description

Time Frame

Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Title

Amount of Rescue Medication Taken

Description

Time Frame

Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Other Pre-specified Outcome Measures:

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state.

Time Frame

Baseline up to 28 days after last dose of study treatment (up to Week 16)

Title

Number of Participants With Anti-Drug Antibody (ADA)

Description

Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).

Time Frame

Baseline up to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female of any race, >18 years of age and have BMI ≤39 kg/m2 Present with duration of chronic low back pain of ≥3 months requiring regular use of analgesic medication (>4 days per week for the past month) Primary location of low back pain is between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment at Screening, and completes at least 4 daily pain diaries during the 5 days prior to Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4 Exclusion Criteria: Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis) History of lumbosacral radiculopathy, spinal stenosis associated with neurological impairment, or neurogenic claudication Osteoporotic compression fracture within the last 6 months Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia; Tumors or infections of the spinal cord Patients receiving acetaminophen only to manage their chronic low back pain Any uncontrolled or untreated chronic disease

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

Pinnacle Research Group LLC

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Radiant Research

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Radiant Research - Phoenix Southeast

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85225

Country

United States

Facility Name

Radiant Research

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Advanced Clinical Research Institute

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

University of California San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

Facility Name

Doctors Medical Center of Walton County

City

DeFuniak Springs

State/Province

Florida

ZIP/Postal Code

32435

Country

United States

Facility Name

SJS Clinical Research, Inc.

City

Destin

State/Province

Florida

ZIP/Postal Code

32541

Country

United States

Facility Name

Adult Medicine Specialists

City

Longwood

State/Province

Florida

ZIP/Postal Code

32779

Country

United States

Facility Name

Genesis Research International

City

Longwood

State/Province

Florida

ZIP/Postal Code

32779

Country

United States

Facility Name

Collier Neurologic Specialists

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Cotton-O'Neil Clinical Research

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Cotton-O'Neil Clinic

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Heartland Research Associates

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Northeast Medical Research Associates, Inc

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Clinical Pharmacology Study Group

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01610

Country

United States

Facility Name

Spence Medical Research

City

Picayune

State/Province

Mississippi

ZIP/Postal Code

39466

Country

United States

Facility Name

Radiant Research, Inc.

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Quality Clinical Research, Inc.

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

The Medical Research Network, LLC

City

New York

State/Province

New York

ZIP/Postal Code

10024

Country

United States

Facility Name

North State Clinical Research, PLLC

City

Lenoir

State/Province

North Carolina

ZIP/Postal Code

28645

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

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Summit Research Network (Oregon), Inc.

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Allegheny Pain Management

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

New England Center for Clinical Research

City

Cranston

State/Province

Rhode Island

ZIP/Postal Code

02920

Country

United States

Facility Name

Partners in Clinical Research

City

Cumberland

State/Province

Rhode Island

ZIP/Postal Code

02864

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

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Advanced Therapeutics, Inc.

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37601

Country

United States

Facility Name

Johnson City Internal Medicine

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37601

Country

United States

Facility Name

DiscoveResearch, Incorporated

City

Bryan

State/Province

Texas

ZIP/Postal Code

77802

Country

United States

Facility Name

Advances In Health, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Centex Research

City

Nassau Bay

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Immediate Medical Care

City

Nassau Bay

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Radiant Research San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Independence Family Medicine

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23455

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

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091004&StudyName=RN624%20In%20Adult%20Patients%20With%20Chronic%20Low%20Back%20Pain

Description

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RN624 In Adult Patients With Chronic Low Back Pain

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RN624 In Adult Patients With Chronic Low Back Pain

Low Back Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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