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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: | 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
Hide Study Locations| Canada | |
| Pfizer Investigational Site | |
| St. John's, Canada, A1C 5B8 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V5Z 1L7 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Kitchener, Ontario, Canada, N2M 5N6 | |
| Pfizer Investigational Site | |
| London, Ontario, Canada, N6A 4V2 | |
| Pfizer Investigational Site | |
| Newmarket, Ontario, Canada, L3Y 3R7 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| SAINTE-FOY, Quebec, Canada, G1V 4G2 | |
| Pfizer Investigational Site | |
| Sainte-Foy, Quebec, Canada, G1V 3M7 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Pfizer Investigational Site | |
| Trois-Revieres, Quebec, Canada, G8Z 1Y2 | |
| France | |
| Pfizer Investigational Site | |
| Digne Les Bains, France, 04000 | |
| Pfizer Investigational Site | |
| Clamart, France, 92140 | |
| Pfizer Investigational Site | |
| Marseille, France, 13008 | |
| Pfizer Investigational Site | |
| LAVAL CEDEX, France, 53015 | |
| Pfizer Investigational Site | |
| Saint Giron, France, 09200 | |
| Pfizer Investigational Site | |
| Saint Genevvieve Des Bois, France, 91700 | |
| Pfizer Investigational Site | |
| Orleans Cedex 01, France, 45032 | |
| Pfizer Investigational Site | |
| Saint Afrique, France, 12400 | |
| Pfizer Investigational Site | |
| Paris Cedex 12, France, 75571 | |
| Pfizer Investigational Site | |
| Limoges, France, 87042 | |
| Pfizer Investigational Site | |
| Langon, France, 33210 | |
| Pfizer Investigational Site | |
| Toulouse, France, 31000 | |
| Pfizer Investigational Site | |
| Saint Etienne, France, 42000 | |
| Pfizer Investigational Site | |
| Vitrolles, France, 13127 | |
| Pfizer Investigational Site | |
| Gonesse, France, 95500 | |
| Pfizer Investigational Site | |
| Issy Les Moulineaux, France, 92130 | |
| Pfizer Investigational Site | |
| Bagnols Sur Ceze, France, 30200 | |
| Pfizer Investigational Site | |
| St. Pierre de Coutances, France, 50200 | |
| Pfizer Investigational Site | |
| VITRE, France, 35500 | |
| Pfizer Investigational Site | |
| Grenoble, France, 38000 | |
| Pfizer Investigational Site | |
| Boulogne Sur Mer, France, 62200 | |
| Pfizer Investigational Site | |
| LYON, France, 69002 | |
| Pfizer Investigational Site | |
| NIMES, France, 30900 | |
| Pfizer Investigational Site | |
| Colmar, France, 68000 | |
| Pfizer Investigational Site | |
| Toulouse, France, 31400 | |
| Pfizer Investigational Site | |
| ORMESSON SUR MARNE, France, 94490 | |
| Pfizer Investigational Site | |
| Nogent le Rotrou, France, 28400 | |
| Pfizer Investigational Site | |
| Orleans Cedex 01, France, 45000 | |
| Pfizer Investigational Site | |
| Clichy, France, 92110 | |
| Pfizer Investigational Site | |
| Reims, France, 51100 | |
| Pfizer Investigational Site | |
| Lyon, France, 69003 | |
| Pfizer Investigational Site | |
| Saint Quentin, France, 02100 | |
| Pfizer Investigational Site | |
| OBERNAI, France, 67210 | |
| Pfizer Investigational Site | |
| Valence, France, 26000 | |
| Pfizer Investigational Site | |
| Orthez, France, 64300 | |
| Pfizer Investigational Site | |
| AVIGNON, France, 84000 | |
| Pfizer Investigational Site | |
| Versailles, France, 78000 | |
| Pfizer Investigational Site | |
| CHATEUAUROUX, France, 36000 | |
| Pfizer Investigational Site | |
| LA ROCHELLE, France, 17000 | |
| Pfizer Investigational Site | |
| NOSEL, France, 77186 | |
| Pfizer Investigational Site | |
| L'union, France, 31240 | |
| Pfizer Investigational Site | |
| IVRY SUR SEINE, France, 94200 | |
| Pfizer Investigational Site | |
| La Celle Saint Cloud, France, 78170 | |
| Pfizer Investigational Site | |
| Montigny le Bretonneux, France, 78180 | |
| Pfizer Investigational Site | |
| Beauvais, France, 6000 | |
| Pfizer Investigational Site | |
| Rennes, France, 35000 | |
| Pfizer Investigational Site | |
| Maisons Alfort, France, 94700 | |
| Pfizer Investigational Site | |
| Petit Quevilly, France, 76140 | |
| Pfizer Investigational Site | |
| Dijon, France, 21000 | |
| Pfizer Investigational Site | |
| Belfort, France, 90000 | |
| Pfizer Investigational Site | |
| Corbeil Essonnes, France, 91100 | |
| Pfizer Investigational Site | |
| Fontainebleau, France, 77300 | |
| Pfizer Investigational Site | |
| STRASBOURG, France, 67000 | |
| Pfizer Investigational Site | |
| Jonzac, France, 17500 | |
| Pfizer Investigational Site | |
| Neufchateau, France, 88300 | |
| Pfizer Investigational Site | |
| Lisieux, France, 14100 | |
| Pfizer Investigational Site | |
| Nice, France, 06000 | |
| Pfizer Investigational Site | |
| Cahors, France, 46000 | |
| Pfizer Investigational Site | |
| Joue Les Tours, France, 37300 | |
| Pfizer Investigational Site | |
| Chaumont, France, 52100 | |
| Pfizer Investigational Site | |
| Toulouse, France, 31076 | |
| Pfizer Investigational Site | |
| Paris, France, 75011 | |
| Pfizer Investigational Site | |
| Moulins, France, 03000 | |
| Pfizer Investigational Site | |
| Nantes, France, 44000 | |
| Pfizer Investigational Site | |
| Montlucon, France, 03100 | |
| Pfizer Investigational Site | |
| Rodez, France, 12000 | |
| Pfizer Investigational Site | |
| Poitiers, France, 86000 | |
| Pfizer Investigational Site | |
| Villeurbanne, France, 69100 | |
| Pfizer Investigational Site | |
| L'Aigle, France, 61300 | |
| Pfizer Investigational Site | |
| Nevers, France, 58000 | |
| Pfizer Investigational Site | |
| Nancy, France, 54000 | |
| Pfizer Investigational Site | |
| Castelnaudary, France, 11400 | |
| Pfizer Investigational Site | |
| Angers, France, 49100 | |
| Pfizer Investigational Site | |
| Lyon, France, 69006 | |
| Pfizer Investigational Site | |
| SAINT MAXIME, France, 83120 | |
| Pfizer Investigational Site | |
| Firminy, France, 42700 | |
| Pfizer Investigational Site | |
| Montpellier, France, 34100 | |
| Pfizer Investigational Site | |
| Landivisiau, France, 29400 | |
| Pfizer Investigational Site | |
| Lyon, France, 69007 | |
| Pfizer Investigational Site | |
| Marseille, France, 13015 | |
| Pfizer Investigational Site | |
| Dax, France, 40100 | |
| Pfizer Investigational Site | |
| Martigues, France, 13500 | |
| Pfizer Investigational Site | |
| Thonon Les Bains, France, 74200 | |
| Pfizer Investigational Site | |
| ARLES, France, 13200 | |
| Pfizer Investigational Site | |
| Le Perreus sur Marne, France, 94000 | |
| Pfizer Investigational Site | |
| ORLY, France, 94310 | |
| Pfizer Investigational Site | |
| Villeneuve sur Lot, France, 47310 | |
| Pfizer Investigational Site | |
| Sartrouville, France, 78500 | |
| Pfizer Investigational Site | |
| Strasbourg, France, 67098 | |
| Pfizer Investigational Site | |
| Les Angles, France, 30133 | |
| Pfizer Investigational Site | |
| TOURS, France, 37000 | |
| Pfizer Investigational Site | |
| Gardanne, France, 13120 | |
| Pfizer Investigational Site | |
| Thionville, France, 57100 | |
| Pfizer Investigational Site | |
| Lunel, France, 34400 | |
| Pfizer Investigational Site | |
| Antibes, France, 06600 | |
| Pfizer Investigational Site | |
| Cannes La Boca, France, 06150 | |
| Pfizer Investigational Site | |
| Creteil, France, 94000 | |
| Pfizer Investigational Site | |
| TOURCOING, France, 59200 | |
| Pfizer Investigational Site | |
| Paris, France, 75015 | |
| Pfizer Investigational Site | |
| Vandoeuvre les Nancy, France, 54500 | |
| Pfizer Investigational Site | |
| Courbevoie, France, 92200 | |
| Pfizer Investigational Site | |
| Libourne Cedex, France, 333505 | |
| Pfizer Investigational Site | |
| Vence, France, 06140 | |
| Pfizer Investigational Site | |
| MONTPELLIER, France, 34295 | |
| Pfizer Investigational Site | |
| Saint Jacques de la Lande, France, 35136 | |
| Pfizer Investigational Site | |
| PÃRIS, France, 75015 | |
| Pfizer Investigational Site | |
| Montgeron, France, 91230 | |
| Pfizer Investigational Site | |
| Marseille Cedex 05, France, 13354 | |
| Pfizer Investigational Site | |
| Paris, France, 75017 | |
| Pfizer Investigational Site | |
| Rennes, France, 1584 | |
| Pfizer Investigational Site | |
| Paris, France, 75020 | |
| Pfizer Investigational Site | |
| Paris, France, 75018 | |
| Pfizer Investigational Site | |
| Epernay, France, 51200 | |
| Pfizer Investigational Site | |
| CORNEBARRIEU, France, 31700 | |
| Pfizer Investigational Site | |
| Toulouse, France, 31054 | |
| Pfizer Investigational Site | |
| Quimper, France, 29000 | |
| Pfizer Investigational Site | |
| Nimes, France, 30900 | |
| Pfizer Investigational Site | |
| Cornebarrieu, France, 31700 | |
| Pfizer Investigational Site | |
| Toulouse, France, 31500 | |
| Pfizer Investigational Site | |
| Montpellier, France, 34070 | |
| Pfizer Investigational Site | |
| CAEN, France, 14000 | |
| Pfizer Investigational Site | |
| THIONVILLE, France, 57100 | |
| Pfizer Investigational Site | |
| Saint Lo, France, 50000 | |
| Pfizer Investigational Site | |
| CHERBOURG, France, 50100 | |
| Pfizer Investigational Site | |
| Puteaux, France, 92800 | |
| 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 |