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Clinical Trial Name - Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.
| Original Study ID : A3191165 |
| NCT ID : NCT00290901 |
| 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. |
| Source : Pfizer |
| Overall Status : Completed |
| Start Date : March 2006 |
| Official Title : Phase 4 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Enrollment : 754 |
| Verification Date : March 2008 |
| First Received Date : February 9, 2006 |
| Trial 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 |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : Accepts He |
| Facilities |
| Facility Name : Pfizer Investigational Site |
| City : Phoenix |
| State : Arizona |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Tucson |
| State : Arizona |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Scottsdale |
| State : Arizona |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Little Rock |
| State : Arkansas |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Long Beach |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Paramount |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Tustin |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Vista |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Anaheim |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Sacramento |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : San Francisco |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : San Luis Obispo |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : San Francisco |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Oceanside |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : La Mesa |
| State : California |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Colorado Springs |
| State : Colorado |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Boulder |
| State : Colorado |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Denver |
| State : Colorado |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Cos Cob |
| State : Connecticut |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Washington |
| State : District of Columbia |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Miami |
| State : Florida |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Pembroke Pines |
| State : Florida |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : West Palm Beach |
| State : Florida |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Woodstock |
| State : Georgia |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Decatur |
| State : Georgia |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Morton Grove |
| State : Illinois |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Libertyville |
| State : Illinois |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Overland Park |
| State : Kansas |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Arkansas City |
| State : Kansas |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Wichita |
| State : Kansas |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Madisonville |
| State : Kentucky |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Wheaton |
| State : Maryland |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Baltimore |
| State : Maryland |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Jackson |
| State : Mississippi |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : St. Louis |
| State : Missouri |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Kansas City |
| State : Missouri |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Omaha |
| State : Nebraska |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Brooklyn |
| State : New York |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : New York |
| State : New York |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Rochester |
| State : New York |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Raleigh |
| State : North Carolina |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Medford |
| State : Oregon |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Portland |
| State : Oregon |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Camp Hill |
| State : Pennsylvania |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Duncansville |
| State : Pennsylvania |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Columbia |
| State : South Carolina |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Charleston |
| State : South Carolina |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : New Tazewell |
| State : Tennessee |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Johnson City |
| State : Tennessee |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : San Antonio |
| State : Texas |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Austin |
| State : Texas |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : San Angelo |
| State : Texas |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Arlington |
| State : Virginia |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Danville |
| State : Virginia |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Rio Piedras |
| State : Virginia |
| Country : Puerto Rico |
| OutComes |
| Primary OutComes |
| Measure : 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. |
| Secondary OutComes |
| Measure : 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. |
| Interventions |
| Type : Drug |
| Name : Tramadol Hydrochloride 50mg |
| Type : Drug |
| Name : Celebrex 200mg |
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