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Please see detailed description for termination reason.
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the change in the minimal JSW of the index hip during the 24-month follow up, compared to baseline. This endpoint will be expressed as the proportion of subjects achieving a 0.5 mm decrease in JSW on a radiograph and |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days with rescue medication usage by drug category: paracetamol /paracetamol combination products, opioid/opioid combination products, celecoxib and other (e.g., propoxyphene) WOMAC subscales: pain and function (in comparison to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Vancouver | British Columbia | V5Z 1L7 | Canada | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Kitchener |
| Ontario |
| N2M 5N6 |
| Canada |
| Pfizer Investigational Site | London | Ontario | N6A 4V2 | Canada |
| Pfizer Investigational Site | Newmarket | Ontario | L3Y 3R7 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2L 4M1 | Canada |
| Pfizer Investigational Site | Sainte-Foy | Quebec | G1V 3M7 | Canada |
| Pfizer Investigational Site | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Pfizer Investigational Site | Trois-Revieres | Quebec | G8Z 1Y2 | Canada |
| Pfizer Investigational Site | St. John's | A1C 5B8 | Canada |
| Pfizer Investigational Site | Angers | 49100 | France |
| Pfizer Investigational Site | Antibes | 06600 | France |
| Pfizer Investigational Site | Arles | 13200 | France |
| Pfizer Investigational Site | Avignon | 84000 | France |
| Pfizer Investigational Site | Bagnols-sur-Cèze | 30200 | France |
| Pfizer Investigational Site | Beauvais | 6000 | France |
| Pfizer Investigational Site | Belfort | 90000 | France |
| Pfizer Investigational Site | Boulogne-sur-Mer | 62200 | France |
| Pfizer Investigational Site | Caen | 14000 | France |
| Pfizer Investigational Site | Cahors | 46000 | France |
| Pfizer Investigational Site | Cannes La Boca | 06150 | France |
| Pfizer Investigational Site | Castelnaudary | 11400 | France |
| Pfizer Investigational Site | Chateuauroux | 36000 | France |
| Pfizer Investigational Site | Chaumont | 52100 | France |
| Pfizer Investigational Site | Cherbourg | 50100 | France |
| Pfizer Investigational Site | Clamart | 92140 | France |
| Pfizer Investigational Site | Clichy | 92110 | France |
| Pfizer Investigational Site | Colmar | 68000 | France |
| Pfizer Investigational Site | Corbeil-Essonnes | 91100 | France |
| Pfizer Investigational Site | Cornebarrieu | 31700 | France |
| Pfizer Investigational Site | Courbevoie | 92200 | France |
| Pfizer Investigational Site | Créteil | 94000 | France |
| Pfizer Investigational Site | Dax | 40100 | France |
| Pfizer Investigational Site | Digne-les-Bains | 04000 | France |
| Pfizer Investigational Site | Dijon | 21000 | France |
| Pfizer Investigational Site | Épernay | 51200 | France |
| Pfizer Investigational Site | Firminy | 42700 | France |
| Pfizer Investigational Site | Fontainebleau | 77300 | France |
| Pfizer Investigational Site | Gardanne | 13120 | France |
| Pfizer Investigational Site | Gonesse | 95500 | France |
| Pfizer Investigational Site | Grenoble | 38000 | France |
| Pfizer Investigational Site | Issy-les-Moulineaux | 92130 | France |
| Pfizer Investigational Site | Ivry-sur-Seine | 94200 | France |
| Pfizer Investigational Site | Jonzac | 17500 | France |
| Pfizer Investigational Site | Joué-lès-Tours | 37300 | France |
| Pfizer Investigational Site | L'Aigle | 61300 | France |
| Pfizer Investigational Site | L'Union | 31240 | France |
| Pfizer Investigational Site | La Celle-Saint-Cloud | 78170 | France |
| Pfizer Investigational Site | La Rochelle | 17000 | France |
| Pfizer Investigational Site | Landivisiau | 29400 | France |
| Pfizer Investigational Site | Langon | 33210 | France |
| Pfizer Investigational Site | Laval | 53015 | France |
| Pfizer Investigational Site | Le Perreus Sur Marne | 94000 | France |
| Pfizer Investigational Site | Le Petit-Quevilly | 76140 | France |
| Pfizer Investigational Site | Les Angles | 30133 | France |
| Pfizer Investigational Site | Libourne | 333505 | France |
| Pfizer Investigational Site | Limoges | 87042 | France |
| Pfizer Investigational Site | Lisieux | 14100 | France |
| Pfizer Investigational Site | Lunel | 34400 | France |
| Pfizer Investigational Site | Lyon | 69002 | France |
| Pfizer Investigational Site | Lyon | 69003 | France |
| Pfizer Investigational Site | Lyon | 69006 | France |
| Pfizer Investigational Site | Lyon | 69007 | France |
| Pfizer Investigational Site | Maisons-Alfort | 94700 | France |
| Pfizer Investigational Site | Marseille | 13008 | France |
| Pfizer Investigational Site | Marseille | 13015 | France |
| Pfizer Investigational Site | Marseille | 13354 | France |
| Pfizer Investigational Site | Martigues | 13500 | France |
| Pfizer Investigational Site | Montgeron | 91230 | France |
| Pfizer Investigational Site | Montigny-le-Bretonneux | 78180 | France |
| Pfizer Investigational Site | Montluçon | 03100 | France |
| Pfizer Investigational Site | Montpellier | 34070 | France |
| Pfizer Investigational Site | Montpellier | 34100 | France |
| Pfizer Investigational Site | Montpellier | 34295 | France |
| Pfizer Investigational Site | Moulins | 03000 | France |
| Pfizer Investigational Site | Nancy | 54000 | France |
| Pfizer Investigational Site | Nantes | 44000 | France |
| Pfizer Investigational Site | Naucelle | 77186 | France |
| Pfizer Investigational Site | Neufchâteau | 88300 | France |
| Pfizer Investigational Site | Nevers | 58000 | France |
| Pfizer Investigational Site | Nice | 06000 | France |
| Pfizer Investigational Site | Nîmes | 30900 | France |
| Pfizer Investigational Site | Nogent-le-Rotrou | 28400 | France |
| Pfizer Investigational Site | Obernai | 67210 | France |
| Pfizer Investigational Site | Orléans | 45000 | France |
| Pfizer Investigational Site | Orléans | 45032 | France |
| Pfizer Investigational Site | Orly | 94310 | France |
| Pfizer Investigational Site | Ormesson-sur-Marne | 94490 | France |
| Pfizer Investigational Site | Orthez | 64300 | France |
| Pfizer Investigational Site | Paris | 75011 | France |
| Pfizer Investigational Site | Paris | 75015 | France |
| Pfizer Investigational Site | Paris | 75017 | France |
| Pfizer Investigational Site | Paris | 75018 | France |
| Pfizer Investigational Site | Paris | 75020 | France |
| Pfizer Investigational Site | Paris | 75571 | France |
| Pfizer Investigational Site | Poitiers | 86000 | France |
| Pfizer Investigational Site | Puteaux | 92800 | France |
| Pfizer Investigational Site | Quimper | 29000 | France |
| Pfizer Investigational Site | Reims | 51100 | France |
| Pfizer Investigational Site | Rennes | 1584 | France |
| Pfizer Investigational Site | Rennes | 35000 | France |
| Pfizer Investigational Site | Rodez | 12000 | France |
| Pfizer Investigational Site | Saint Afrique | 12400 | France |
| Pfizer Investigational Site | Saint Genevvieve Des Bois | 91700 | France |
| Pfizer Investigational Site | Saint Giron | 09200 | France |
| Pfizer Investigational Site | Saint Maxime | 83120 | France |
| Pfizer Investigational Site | Saint-Etienne | 42000 | France |
| Pfizer Investigational Site | Saint-Jacques-de-la-Lande | 35136 | France |
| Pfizer Investigational Site | Saint-Lô | 50000 | France |
| Pfizer Investigational Site | Saint-Pierre-de-Coutances | 50200 | France |
| Pfizer Investigational Site | Saint-Quentin | 02100 | France |
| Pfizer Investigational Site | Sartrouville | 78500 | France |
| Pfizer Investigational Site | Strasbourg | 67000 | France |
| Pfizer Investigational Site | Strasbourg | 67098 | France |
| Pfizer Investigational Site | Thionville | 57100 | France |
| Pfizer Investigational Site | Thonon-les-Bains | 74200 | France |
| Pfizer Investigational Site | Toulouse | 31000 | France |
| Pfizer Investigational Site | Toulouse | 31054 | France |
| Pfizer Investigational Site | Toulouse | 31076 | France |
| Pfizer Investigational Site | Toulouse | 31400 | France |
| Pfizer Investigational Site | Toulouse | 31500 | France |
| Pfizer Investigational Site | Tourcoing | 59200 | France |
| Pfizer Investigational Site | Tours | 37000 | France |
| Pfizer Investigational Site | Valence | 26000 | France |
| Pfizer Investigational Site | Vandœuvre-lès-Nancy | 54500 | France |
| Pfizer Investigational Site | Vence | 06140 | France |
| Pfizer Investigational Site | Versailles | 78000 | France |
| Pfizer Investigational Site | Villeneuve-sur-Lot | 47310 | France |
| Pfizer Investigational Site | Villeurbanne | 69100 | France |
| Pfizer Investigational Site | Vitré | 35500 | France |
| Pfizer Investigational Site | Vitrolles | 13127 | France |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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