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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00290901 |
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 | Intervention | Phase |
---|---|---|
Back Pain |
Drug: Tramadol Hydrochloride 50mg Drug: Celebrex 200mg |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 754 |
Study Start Date: | March 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | A3191165 |
Study First Received: | February 9, 2006 |
Last Updated: | March 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00290901 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Celecoxib Tramadol Neurologic Manifestations |
Low Back Pain Pain Back Pain |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Central Nervous System Depressants Narcotics Enzyme Inhibitors Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Analgesics, Opioid |