Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.
Overview[ - collapse ][ - ]
| Purpose | This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period. |
|---|---|
| Condition | Back Pain |
| Intervention | Drug: Tramadol Hydrochloride 50mg Drug: Celebrex 200mg |
| Phase | Phase 4 |
| Sponsor | Pfizer |
| Responsible Party | Pfizer |
| ClinicalTrials.gov Identifier | NCT00290901 |
| First Received | February 9, 2006 |
| Last Updated | March 21, 2008 |
| Last verified | March 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 9, 2006 |
|---|---|
| Last Updated Date | March 21, 2008 |
| Start Date | March 2006 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6. |
| Current Secondary Outcome Measures | To compare the effects of treatment with celecoxib 200 mg BID and tramadol hydrochloride 50 mg QID on improvement in functionality and quality of life in subjects with chronic low back pain. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. |
|---|---|
| Official Title | A Six Week Double-Blind, Randomized, Multicenter Comparison Study of the Analgesic Effectiveness of Celecoxib 200 mg BID Compared to Tramadol Hydrochloride 50 mg QID in Subjects With Chronic Low Back Pain |
| Brief Summary | This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Back Pain |
| Intervention | Drug: Tramadol Hydrochloride 50mg Drug: Celebrex 200mg |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 754 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | December 2006 |
| Eligibility Criteria | Inclusion Criteria: - The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used. Exclusion Criteria: - The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy) |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States, Puerto Rico |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00290901 |
|---|---|
| Other Study ID Numbers | A3191165 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Pfizer |
| Study Sponsor | Pfizer |
| Collaborators | Not Provided |
| Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
| Verification Date | March 2008 |
Locations[ + expand ][ + ]
| Pfizer Investigational Site | Phoenix, Arizona, United States |
|---|---|
| Pfizer Investigational Site | Scottsdale, Arizona, United States |
| Pfizer Investigational Site | Tucson, Arizona, United States |
| Pfizer Investigational Site | Little Rock, Arkansas, United States |
| Pfizer Investigational Site | Anaheim, California, United States |
| Pfizer Investigational Site | La Mesa, California, United States |
| Pfizer Investigational Site | Long Beach, California, United States |
| Pfizer Investigational Site | Oceanside, California, United States |
| Pfizer Investigational Site | Paramount, California, United States |
| Pfizer Investigational Site | Sacramento, California, United States |
| Pfizer Investigational Site | San Francisco, California, United States |
| Pfizer Investigational Site | San Luis Obispo, California, United States |
| Pfizer Investigational Site | Tustin, California, United States |
| Pfizer Investigational Site | Vista, California, United States |
| Pfizer Investigational Site | Boulder, Colorado, United States |
| Pfizer Investigational Site | Colorado Springs, Colorado, United States |
| Pfizer Investigational Site | Denver, Colorado, United States |
| Pfizer Investigational Site | Cos Cob, Connecticut, United States |
| Pfizer Investigational Site | Washington, District of Columbia, United States |
| Pfizer Investigational Site | Miami, Florida, United States |
| Pfizer Investigational Site | Pembroke Pines, Florida, United States |
| Pfizer Investigational Site | West Palm Beach, Florida, United States |
| Pfizer Investigational Site | Decatur, Georgia, United States |
| Pfizer Investigational Site | Woodstock, Georgia, United States |
| Pfizer Investigational Site | Libertyville, Illinois, United States |
| Pfizer Investigational Site | Morton Grove, Illinois, United States |
| Pfizer Investigational Site | Arkansas City, Kansas, United States |
| Pfizer Investigational Site | Overland Park, Kansas, United States |
| Pfizer Investigational Site | Wichita, Kansas, United States |
| Pfizer Investigational Site | Madisonville, Kentucky, United States |
| Pfizer Investigational Site | Baltimore, Maryland, United States |
| Pfizer Investigational Site | Wheaton, Maryland, United States |
| Pfizer Investigational Site | Jackson, Mississippi, United States |
| Pfizer Investigational Site | Kansas City, Missouri, United States |
| Pfizer Investigational Site | St. Louis, Missouri, United States |
| Pfizer Investigational Site | Omaha, Nebraska, United States |
| Pfizer Investigational Site | Brooklyn, New York, United States |
| Pfizer Investigational Site | New York, New York, United States |
| Pfizer Investigational Site | Rochester, New York, United States |
| Pfizer Investigational Site | Raleigh, North Carolina, United States |
| Pfizer Investigational Site | Medford, Oregon, United States |
| Pfizer Investigational Site | Portland, Oregon, United States |
| Pfizer Investigational Site | Camp Hill, Pennsylvania, United States |
| Pfizer Investigational Site | Duncansville, Pennsylvania, United States |
| Pfizer Investigational Site | Charleston, South Carolina, United States |
| Pfizer Investigational Site | Columbia, South Carolina, United States |
| Pfizer Investigational Site | Johnson City, Tennessee, United States |
| Pfizer Investigational Site | New Tazewell, Tennessee, United States |
| Pfizer Investigational Site | Austin, Texas, United States |
| Pfizer Investigational Site | San Angelo, Texas, United States |
| Pfizer Investigational Site | San Antonio, Texas, United States |
| Pfizer Investigational Site | Arlington, Virginia, United States |
| Pfizer Investigational Site | Danville, Virginia, United States |
| Pfizer Investigational Site | Rio Piedras, Puerto Rico |