|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 134 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Study ID Numbers: | A3191068 |
| Study First Received: | September 9, 2005 |
| Last Updated: | July 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00163241 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Osteoarthritis Joint Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Osteoarthritis, Hip Rheumatic Diseases Pharmacologic Actions |
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 |