Effect Of Celecoxib On Hip Osteoarthritis (OA) Progression

NCT00163241 | Terminated Phase 3

• 1 other identifier: A3191068
• Study Type: interventional
• Target: 666
• Locations: 2 countries
• Sites: 130

Brief Summary

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Interventions

celecoxib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is 50 years of age or older.
• If the subject is a female and of childbearing potential, or less than 2 years post-menopausal, she must have been using adequate contraception during her last menses and will use adequate contraception during the study, is not lactating, and has had a negative urine pregnancy test within 24 hours prior to receiving the first dose of study medication. Women less than two years post-menopausal are considered of childbearing potential for the purposes of this study.
• The subject is diagnosed as having OA of the hip as defined by the American College of Rheumatology (ACR) criteria (see Appendix B)
• The subject has symptomatic OA, as defined by the presence of daily hip pain for at least 1 month (not necessarily continuously) during the 2 months prior to screening visit.
• The subject has hip pain of \> or equal to 3 and \< or equal to 9 on a 10-point Visual Numerical Scale (VNS) in the index hip.
• Subjects with OA of the knee associated with OA of the hip will be included provided knee OA pain intensity is inferior to hip's one and no knee surgery is expected during the study.
• Subjects are functional class I, II or III according to the Steinbrocker criteria (see Appendix C).
• The subject is eligible for pharmacologic treatment to control arthritis symptoms.
• The subject has provided written informed consent before undergoing any study procedures.

You may not qualify if:

• Bilateral hip OA with contralateral hip more severe symptomatically or radiologically than the index hip.
• The subject has evidence of secondary hip OA.
• Septic arthritis
• Systemic or local inflammatory joint disease (e.g. psoriatic arthritis, spondylarthropathy, systemic lupus erythematosus, etc.)
• Gout
• Recurrent episode of pseudogout
• Paget's disease
• Articular fracture
• Ochronosis
• Acromegaly
• Haemochromatosis
• Wilson's disease
• Primary osteochondromatosis
• Osteonecrosis
• Slipped Capital Femoral Epiphysis (SCFE)

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (130)

Pfizer Investigational Site

Vancouver, British Columbia, V5Z 1L7, Canada

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Kitchener, Ontario, N2M 5N6, Canada

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London, Ontario, N6A 4V2, Canada

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Newmarket, Ontario, L3Y 3R7, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Sainte-Foy, Quebec, G1V 3M7, Canada

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Sainte-Foy, Quebec, G1V 4G2, Canada

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Trois-Revieres, Quebec, G8Z 1Y2, Canada

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St. John's, A1C 5B8, Canada

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Angers, 49100, France

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Antibes, 06600, France

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Arles, 13200, France

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Avignon, 84000, France

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Bagnols-sur-Cèze, 30200, France

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Beauvais, 6000, France

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Belfort, 90000, France

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Boulogne-sur-Mer, 62200, France

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Caen, 14000, France

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Cahors, 46000, France

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Cannes La Boca, 06150, France

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Castelnaudary, 11400, France

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Chateuauroux, 36000, France

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Chaumont, 52100, France

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Cherbourg, 50100, France

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Clamart, 92140, France

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Clichy, 92110, France

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Colmar, 68000, France

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Corbeil-Essonnes, 91100, France

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Cornebarrieu, 31700, France

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Courbevoie, 92200, France

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Créteil, 94000, France

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Dax, 40100, France

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Digne-les-Bains, 04000, France

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Dijon, 21000, France

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Épernay, 51200, France

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Firminy, 42700, France

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Fontainebleau, 77300, France

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Gardanne, 13120, France

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Gonesse, 95500, France

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Grenoble, 38000, France

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Issy-les-Moulineaux, 92130, France

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Ivry-sur-Seine, 94200, France

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Jonzac, 17500, France

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Joué-lès-Tours, 37300, France

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L'Aigle, 61300, France

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L'Union, 31240, France

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La Celle-Saint-Cloud, 78170, France

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La Rochelle, 17000, France

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Landivisiau, 29400, France

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Langon, 33210, France

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Laval, 53015, France

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Le Perreus Sur Marne, 94000, France

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Le Petit-Quevilly, 76140, France

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Les Angles, 30133, France

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Libourne, 333505, France

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Limoges, 87042, France

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Lisieux, 14100, France

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Lunel, 34400, France

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Lyon, 69002, France

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Lyon, 69003, France

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Lyon, 69006, France

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Lyon, 69007, France

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Maisons-Alfort, 94700, France

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Marseille, 13008, France

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Marseille, 13015, France

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Marseille, 13354, France

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Martigues, 13500, France

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Montgeron, 91230, France

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Montigny-le-Bretonneux, 78180, France

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Montluçon, 03100, France

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Montpellier, 34070, France

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Montpellier, 34100, France

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Montpellier, 34295, France

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Moulins, 03000, France

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Nancy, 54000, France

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Nantes, 44000, France

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Naucelle, 77186, France

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Neufchâteau, 88300, France

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Nevers, 58000, France

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Nice, 06000, France

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Nîmes, 30900, France

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Nogent-le-Rotrou, 28400, France

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Obernai, 67210, France

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Orléans, 45000, France

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Orléans, 45032, France

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Orly, 94310, France

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Ormesson-sur-Marne, 94490, France

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Orthez, 64300, France

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Paris, 75011, France

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Paris, 75015, France

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Paris, 75017, France

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Paris, 75018, France

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Paris, 75020, France

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Paris, 75571, France

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Poitiers, 86000, France

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Puteaux, 92800, France

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Quimper, 29000, France

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Reims, 51100, France

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Rennes, 1584, France

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Rennes, 35000, France

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Rodez, 12000, France

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Saint Afrique, 12400, France

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Saint Genevvieve Des Bois, 91700, France

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Saint Giron, 09200, France

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Saint Maxime, 83120, France

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Saint-Etienne, 42000, France

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Saint-Jacques-de-la-Lande, 35136, France

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Saint-Lô, 50000, France

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Saint-Pierre-de-Coutances, 50200, France

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Saint-Quentin, 02100, France

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Sartrouville, 78500, France

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Strasbourg, 67000, France

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Strasbourg, 67098, France

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Thionville, 57100, France

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Thonon-les-Bains, 74200, France

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Toulouse, 31000, France

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Toulouse, 31054, France

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Toulouse, 31076, France

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Toulouse, 31400, France

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Toulouse, 31500, France

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Tourcoing, 59200, France

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Tours, 37000, France

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Valence, 26000, France

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Vandœuvre-lès-Nancy, 54500, France

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Vence, 06140, France

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Versailles, 78000, France

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Villeneuve-sur-Lot, 47310, France

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Villeurbanne, 69100, France

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Vitré, 35500, France

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Vitrolles, 13127, France

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Osteoarthritis

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: June 1, 2004
• Study Completion: January 1, 2006
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

FR (121); CA (9)