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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00662558 |
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
Condition | Intervention | Phase |
---|---|---|
Back Pain |
Drug: celecoxib Drug: tramadol HCL |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), 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 |
Enrollment: | 802 |
Study Start Date: | January 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
celecoxib: Experimental |
Drug: celecoxib
200 mg capsules BID for 6 weeks
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tramadol: Active Comparator |
Drug: tramadol HCL
50 mg capsules QID for 6 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191338 |
Study First Received: | December 6, 2007 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00662558 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Celecoxib Tramadol Cyclooxygenase Inhibitors Low Back Pain Central Nervous System Depressants Pain Narcotics Back Pain |
Signs and Symptoms Analgesics, Non-Narcotic Neurologic Manifestations Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Analgesics, Opioid |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Pain Signs and Symptoms Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Analgesics, Opioid Celecoxib Tramadol Nervous System Diseases |
Cyclooxygenase Inhibitors Low Back Pain Central Nervous System Depressants Narcotics Enzyme Inhibitors Back Pain Pharmacologic Actions Analgesics, Non-Narcotic Neurologic Manifestations Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |