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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03243084 -
Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy
|
N/A | |
| Suspended |
NCT04735185 -
Stem Cells vs. Steroids for Discogenic Back Pain
|
N/A | |
| Completed |
NCT03162952 -
RAND Center of Excellence for the Study of Appropriateness of Care in CAM
|
||
| Completed |
NCT03240146 -
Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain
|
N/A | |
| Completed |
NCT05282589 -
Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients
|
N/A | |
| Completed |
NCT03637998 -
Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain
|
N/A | |
| Recruiting |
NCT02289170 -
Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
|
N/A | |
| Active, not recruiting |
NCT01944163 -
The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain
|
N/A | |
| Completed |
NCT02231554 -
Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial
|
N/A | |
| Recruiting |
NCT02063503 -
Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients
|
N/A | |
| Terminated |
NCT01620775 -
MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain
|
N/A | |
| Completed |
NCT01704677 -
Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up
|
N/A | |
| Completed |
NCT01177280 -
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes
|
N/A | |
| Completed |
NCT01490905 -
A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain
|
Phase 4 | |
| Completed |
NCT01177241 -
Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids
|
N/A | |
| Completed |
NCT01177254 -
Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions
|
N/A | |
| Completed |
NCT00984815 -
Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
|
Phase 3 | |
| Completed |
NCT00763321 -
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
|
Phase 3 | |
| Completed |
NCT00761150 -
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
|
Phase 3 | |
| Completed |
NCT00767806 -
A Study for Patient With Chronic Low Back Pain
|
Phase 3 |