Chronic Low Back Pain Clinical Trial
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
| Verified date | May 2016 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
PF-06372865 In Subjects With Chronic Low Back Pain
| Status | Completed |
| Enrollment | 222 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Global Research | Anaheim | California |
| United States | Better Health Clinical Research, Inc. | Atlanta | Georgia |
| United States | River Birch Research Alliance, LLC | Blue Ridge | Georgia |
| United States | Boston Clinical Trials | Boston | Massachusetts |
| United States | Chicago Anesthesia Associates | Chicago | Illinois |
| United States | Columbus Regional Research Institute | Columbus | Georgia |
| United States | Family Medicine center | Columbus | Georgia |
| United States | Avail Clinical Research, LLC | DeLand | Florida |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | S&W Clinical Research | Fort Lauderdale | Florida |
| United States | Neuro-Pain Medical Center | Fresno | California |
| United States | Florida Research Network, LLC | Gainesville | Florida |
| United States | Drug Trials America | Hartsdale | New York |
| United States | Broward Research Group | Hollywood | Florida |
| United States | Clinical Trial Network | Houston | Texas |
| United States | CRC of Jackson | Jackson | Mississippi |
| United States | Physician's Surgery Center | Jackson | Mississippi |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | Centex Studies, Inc | Lake Charles | Louisiana |
| United States | Drug Studies America | Marietta | Georgia |
| United States | Agave Clinical Research, LLC | Mesa | Arizona |
| United States | ActivMed Practices & Research, Inc. | Methuen | Massachusetts |
| United States | Better Health Clinical Research, Inc. | Newnan | Georgia |
| United States | Better Health Clinical Research, Inc./Georgia Pain & Spine Care, Inc. | Newnan | Georgia |
| United States | National Clinical Research - Norfolk, Inc. | Norfolk | Virginia |
| United States | Providence Clinical Research | North Hollywood | California |
| United States | Compass Research, LLC | Orlando | Florida |
| United States | Pines Clinical Research Inc. | Pembroke Pines | Florida |
| United States | Arizona Research Center, Inc. | Phoenix | Arizona |
| United States | Accord Clinical Research, LLC | Port Orange | Florida |
| United States | Summit Research Network (Oregon), Inc. | Portland | Oregon |
| United States | Wake Internal Medicine Consultants, Inc. | Raleigh | North Carolina |
| United States | Wake Research Associates, LLC | Raleigh | North Carolina |
| United States | AAIR Research Center | Rochester | New York |
| United States | Lee Medical Associates, PA | San Antonio | Texas |
| United States | Progressive Clinical Research | San Antonio | Texas |
| United States | Southeast Regional Research Group | Savannah | Georgia |
| United States | Summit Research Network (Seattle) LLC | Seattle | Washington |
| United States | Arthritis & Rheumatic Care Center | South Miami | Florida |
| United States | Miami Research Associates | South Miami | Florida |
| United States | Stamford Therapeutics Consortium | Stamford | Connecticut |
| United States | Omega Medical Research | Warwick | Rhode Island |
| United States | Elite Clinical Trials, Incorporate | Wildomar | California |
| United States | The Center for Clinical Research | Winston-Salem | North Carolina |
| United States | North Georgia Clinical Research | Woodstock | Georgia |
| United States | North Georgia Internal medicine | Woodstock | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy of PF-06372865 vs placebo | 4 weeks | No | |
| Primary | Safety and tolerability of PF-06372865 | up to 28 days post last dose | Yes | |
| Secondary | Efficacy of PF-06372865 vs naproxen | 4 weeks | No | |
| Secondary | Characterize timecourse of analgesia associated with PF-06372865 | 4 weeks | No | |
| Secondary | Evaluate PF-06372865 on functional status | 4 weeks | No | |
| Secondary | Evaluate PF-06372865 on learning efficiency | 4 weeks | No | |
| Secondary | Evaluate subject's assessment of the study medication | 4 weeks | No | |
| Secondary | Plasma exposure of PF-06372865 and naproxen | 4 weeks | No |
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