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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00163241 |
Purpose
Objectives of the study:
Primary: Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo administered once daily (QD) for 24 months in slowing disease progression as assessed radiographically in subjects with osteoarthritis (OA) of the hipSecondary:Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo administered QD for 24 months in treating disease signs and symptoms in subjects with OA of the hip.Evaluate the ability of a continuous 24-month intake of celecoxib 200 mg QD versus placebo to reduce number of subjects eligible for hip replacement according to the investigator.Evaluate the tolerability and safety of a continuous 24-month intake of celecoxib 200 mg QD versus placebo in subjects with OA of the hip.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: celecoxib |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Double-Blind, Placebo-Controlled, Randomized 24-Month Study, Assessing The Effect Of Celecoxib (Celebrex) Long Term Treatment On Hip Osteoarthritis (OA) Progression OSCARE |
| Estimated Enrollment: | 666 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | January 2006 |
The study was terminated on 19 January 2006, prematurely, as a result of low enrollment Safety concerns did not lead to the decision to terminate this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 131 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| ClinicalTrials.gov Identifier: | NCT00163241 History of Changes |
| Other Study ID Numbers: | A3191068 |
| Study First Received: | September 9, 2005 |
| Last Updated: | July 17, 2007 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Osteoarthritis Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |