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Sponsored by: |
Biovail Laboratories International SRL |
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Information provided by: | Biovail Laboratories International SRL |
ClinicalTrials.gov Identifier: | NCT00348452 |
The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER 100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate to severe pain due to OA. For the purposes of this study, celecoxib will serve as a positive control to validate the sensitivity of the model. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of moderate to severe pain due to OA.
Condition | Intervention | Phase |
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Chronic Pain |
Drug: tramadol HCl ER; celecoxib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Randomized, Dose-Ranging, Parallel-Group Comparison of the Efficacy and Safety of Extended Release Tramadol Hydrochloride (Tramadol HCl ER) 100 Mg, 200 Mg, 300 Mg, Celecoxib 200 Mg and Placebo in the Treatment of Osteoarthritis of the Knee and/or Hip. |
Estimated Enrollment: | 1000 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | August 2003 |
Immediate release (IR) tramadol has demonstrated efficacy in several pain conditions including, obstetrical, gynecological, orthopedic, abdominal, and oral surgery. The short elimination half-life of IR tramadol necessitates every 4-6 hour dosing to maintain optimum levels of analgesia in chronic pain. The study medication in this study is a once-daily, extended release (ER) tramadol formulation. This is a 12-week multicenter, double-blind, randomized, dose-ranging, placebo and positive-controlled, parallel-group study. For the purpose of this study, celecoxib serves as a positive control to validate the sensitivity of the model. Patients with OA functional Class I-III of the knee or hip, with moderate to severe pain are eligible for participation, if appropriate criteria are met. During a 2-7 day washout period, the use of all analgesic medications will be discontinued. Eligible patients experiencing moderate to severe pain (>= 40 mm on a 100 mm visual analog scale) in the index joint to be evaluated and who meet all other study criteria will enter the double-blind titration period. During this period, patients will be randomly assigned to receive treatment with tramadol HCl ER 100 mg, 200 mg, 300 mg, celecoxib 200 mg or placebo, once daily. During the titration period (Days 1-9) all patients will be contacted by phone every few days to ensure they do not experience unmanageable pain or unacceptable side effects. Efficacy and safety evaluations will be collected at study visits occurring at Weeks
1, 2, 3, 6, 9 and 12 or at the time of early termination. Study medication will be discontinued at Week 12 and patients will return after 1 week for a post-treatment visit (Week 13).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | B02.CT3.021.TRA P03 |
Study First Received: | July 3, 2006 |
Last Updated: | July 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00348452 History of Changes |
Health Authority: | United States: Food and Drug Administration |
osteoarthritis pain; knee; hip; extended release analgesia; opioid |
Anti-Inflammatory Agents Celecoxib Osteoarthritis Tramadol Joint Diseases Cyclooxygenase Inhibitors Central Nervous System Depressants Narcotics Pain Rheumatic Diseases |
Osteoarthritis, Knee Musculoskeletal Diseases Analgesics, Non-Narcotic Arthritis Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Analgesics, Opioid |
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Osteoarthritis Tramadol Joint Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Central Nervous System Depressants Enzyme Inhibitors Narcotics Rheumatic Diseases |
Pharmacologic Actions Musculoskeletal Diseases Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Arthritis Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Analgesics, Opioid |