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Sponsored by: |
University Hospitals of Cleveland |
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Information provided by: | University Hospitals of Cleveland |
ClinicalTrials.gov Identifier: | NCT00597415 |
The purpose of this study is to compare the efficacy of celecoxib versus placebo in delaying the onset of pain and improving walking function in subjects with knee Osteoarthritis
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis of the Knee |
Drug: celecoxib Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Randomized, Crossover Pilot Study of the Efficacy of Celecoxib 200 mg QD in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee. |
Estimated Enrollment: | 30 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A 1: Placebo Comparator
A 1=placebo
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Drug: placebo
placebo
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A 2: Active Comparator
A 2=celecoxib
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Drug: celecoxib
celecoxib 200mg
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We have developed a walking model that safely and reproducibly induces pain in subjects with knee OA in a manner that permits the comparison of the effect of different therapies on pain control. In a previous study, we demonstrated that a self-paced 20 minute walk followed by a one-hour rest and a second coordinator-paced 20-minute walk was well tolerated and generated moderate to severe pain in all participants within the time frame of the walk. We will now use this model, but with a crossover design to test the efficacy of celecoxib compared to placebo for the control of knee pain and improvement of walking function.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of the following drugs:
Contact: Michelle Wallette, CMA, CCRC | 216-591-1443 ext 15 | michelle.wallette@uhhospitals.org |
Contact: Mary Lesko, CNP | 216-591-1443 ext 13 | mary.lesko@uhhospitals.org |
United States, Ohio | |
University Hospitals Case Medical Center | Recruiting |
Beachwood, Ohio, United States, 44122 | |
Principal Investigator: Nora G Singer, MD | |
Sub-Investigator: Mary Lesko, CNP |
Principal Investigator: | Nora G Singer, MD | UHCMC |
Responsible Party: | University Hospitals Case Medical Center ( Nora G. Singer MD ) |
Study ID Numbers: | Pfizer walking model, UH IRB 06-04-41 |
Study First Received: | January 9, 2008 |
Last Updated: | January 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00597415 History of Changes |
Health Authority: | United States: Institutional Review Board |
Osteoarthritis Knee pain |
Anti-Inflammatory Agents Celecoxib Osteoarthritis Joint Diseases Cyclooxygenase Inhibitors Pain Rheumatic Diseases Osteoarthritis, Knee |
Musculoskeletal Diseases Analgesics, Non-Narcotic Arthritis Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Osteoarthritis Joint Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Rheumatic Diseases Pharmacologic Actions Osteoarthritis, Knee |
Musculoskeletal Diseases Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Arthritis Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |