Effect Of Celecoxib On Hip Osteoarthritis (OA) Progression

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00163241
• Other study ID #: A3191068
• Status: Terminated
• Phase: Phase 3
• Start date: June 2004
• Est. completion date: January 2006

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 666
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

• The subject has a concomitant inflammatory rheumatic condition, which may interfere with the assessment of OA, or acute joint trauma at the index hip.

• The subject has received oral, intramuscular, intravenous, or soft tissue injection of corticosteroids within 4 weeks prior to the screening visit.

• The subject has received an intra-articular injection of corticosteroids or hyaluronic acid in the index hip within 12 weeks prior to the screening visit.

• The subject has received diacerein, chondroitin sulfate, glucosamine sulfate, doxycycline or avocado/soybean unsaponifiables within 12 weeks prior to the screening visit.

• Arthroscopy or a corrective surgery of the index hip has been performed.

• Arthroscopy or a corrective surgery of the contralateral hip has been performed within the 6 months prior to the screening visit .

• Total replacement of the contralateral hip joint was performed within 6 months prior to the screening visit.

• The subject is felt to require hip arthroplasty by the investigator at screening visit.

• The subject has an active malignancy of any type. Subjects who have a history of basal cell carcinoma that has been successfully treated are acceptable. Subjects with a history of other malignancies that have been successfully treated and who have no evidence of recurrence for at least 5 years before study are also acceptable.

• The subject has been diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to the screening visit.

• The subject has a history of recurrent ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any other condition, which in the investigator's opinion might preclude use of NSAIDs.

• The subject has a history of intolerance to paracetamol, opioids and tramadol such that it is felt that an adequate non-anti-inflammatory rescue analgesic regimen cannot be safely prescribed, or has a history of alcohol or substance abuse.

• The subject has known hypersensitivity to celecoxib, demonstrated allergic-type reactions to sulfonamides, experienced asthma, urticaria or allergic-type reactions after taking sulfonamides, aspirin (acetylsalicylic acid [ASA]), lactose or NSAIDs.

• The subject has been diagnosed as having or has been treated for gastrointestinal bleeding within 30 days before the screening visit.

• The subject has previously been admitted to this study.

• The subject has a likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (see Section 9 "Concomitant therapy").

• The subject has severe disease, likely to jeopardize the planned completion of the study

• The subject has abnormal baseline findings and or any other condition, which, in the investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.

• The subject is not literate in French nor English or is unable according to the investigator to answer questions.

• The subject has received any investigational drug within 30 days prior to the screening visit.

• The subject has a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.

• The subject has congestive heart failure (Class II-IV).

• The subject is using aspirin, including low dose aspirin.

• The subject is using other antiplatelet agents (ticlopidine, clopidogrel, dipyridamole).

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Drug:
• celecoxib

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Kitchener	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Newmarket	Ontario
Canada	Pfizer Investigational Site	Sainte-Foy	Quebec
Canada	Pfizer Investigational Site	Sainte-foy	Quebec
Canada	Pfizer Investigational Site	St. John's
Canada	Pfizer Investigational Site	Trois-Revieres	Quebec
Canada	Pfizer Investigational Site	Vancouver	British Columbia
France	Pfizer Investigational Site	Angers
France	Pfizer Investigational Site	Antibes
France	Pfizer Investigational Site	Arles
France	Pfizer Investigational Site	Avignon
France	Pfizer Investigational Site	Bagnols Sur Ceze
France	Pfizer Investigational Site	Beauvais
France	Pfizer Investigational Site	Belfort
France	Pfizer Investigational Site	Boulogne Sur Mer
France	Pfizer Investigational Site	Caen
France	Pfizer Investigational Site	Cahors
France	Pfizer Investigational Site	Cannes La Boca
France	Pfizer Investigational Site	Castelnaudary
France	Pfizer Investigational Site	Chateuauroux
France	Pfizer Investigational Site	Chaumont
France	Pfizer Investigational Site	Cherbourg
France	Pfizer Investigational Site	Clamart
France	Pfizer Investigational Site	Clichy
France	Pfizer Investigational Site	Colmar
France	Pfizer Investigational Site	Corbeil Essonnes
France	Pfizer Investigational Site	Cornebarrieu
France	Pfizer Investigational Site	Courbevoie
France	Pfizer Investigational Site	Creteil
France	Pfizer Investigational Site	Dax
France	Pfizer Investigational Site	Digne Les Bains
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Epernay
France	Pfizer Investigational Site	Firminy
France	Pfizer Investigational Site	Fontainebleau
France	Pfizer Investigational Site	Gardanne
France	Pfizer Investigational Site	Gonesse
France	Pfizer Investigational Site	Grenoble
France	Pfizer Investigational Site	Issy Les Moulineaux
France	Pfizer Investigational Site	Ivry Sur Seine
France	Pfizer Investigational Site	Jonzac
France	Pfizer Investigational Site	Joue Les Tours
France	Pfizer Investigational Site	L'Aigle
France	Pfizer Investigational Site	L'union
France	Pfizer Investigational Site	La Celle Saint Cloud
France	Pfizer Investigational Site	La Rochelle
France	Pfizer Investigational Site	Landivisiau
France	Pfizer Investigational Site	Langon
France	Pfizer Investigational Site	Laval Cedex
France	Pfizer Investigational Site	Le Perreus Sur Marne
France	Pfizer Investigational Site	Les Angles
France	Pfizer Investigational Site	Libourne Cedex
France	Pfizer Investigational Site	Limoges
France	Pfizer Investigational Site	Lisieux
France	Pfizer Investigational Site	Lunel
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Maisons Alfort
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Marseille Cedex 05
France	Pfizer Investigational Site	Martigues
France	Pfizer Investigational Site	Montgeron
France	Pfizer Investigational Site	Montigny le Bretonneux
France	Pfizer Investigational Site	Montlucon
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Moulins
France	Pfizer Investigational Site	Nancy
France	Pfizer Investigational Site	Nantes
France	Pfizer Investigational Site	Neufchateau
France	Pfizer Investigational Site	Nevers
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Nimes
France	Pfizer Investigational Site	Nogent le Rotrou
France	Pfizer Investigational Site	Nosel
France	Pfizer Investigational Site	Obernai
France	Pfizer Investigational Site	Orleans Cedex 01
France	Pfizer Investigational Site	Orleans Cedex 01
France	Pfizer Investigational Site	Orly
France	Pfizer Investigational Site	Ormesson Sur Marne
France	Pfizer Investigational Site	Orthez
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris Cedex 12
France	Pfizer Investigational Site	Petit Quevilly
France	Pfizer Investigational Site	Poitiers
France	Pfizer Investigational Site	Puteaux
France	Pfizer Investigational Site	Quimper
France	Pfizer Investigational Site	Reims
France	Pfizer Investigational Site	Rennes
France	Pfizer Investigational Site	Rennes
France	Pfizer Investigational Site	Rodez
France	Pfizer Investigational Site	Saint Afrique
France	Pfizer Investigational Site	Saint Etienne
France	Pfizer Investigational Site	Saint Genevvieve Des Bois
France	Pfizer Investigational Site	Saint Giron
France	Pfizer Investigational Site	Saint Jacques de la Lande
France	Pfizer Investigational Site	Saint Lo
France	Pfizer Investigational Site	Saint Maxime
France	Pfizer Investigational Site	Saint Quentin
France	Pfizer Investigational Site	Sartrouville
France	Pfizer Investigational Site	St. Pierre de Coutances
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Thionville
France	Pfizer Investigational Site	Thonon Les Bains
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Tourcoing
France	Pfizer Investigational Site	Tours
France	Pfizer Investigational Site	Valence
France	Pfizer Investigational Site	Vandoeuvre les Nancy
France	Pfizer Investigational Site	Vence
France	Pfizer Investigational Site	Versailles
France	Pfizer Investigational Site	Villeneuve sur Lot
France	Pfizer Investigational Site	Villeurbanne
France	Pfizer Investigational Site	Vitre
France	Pfizer Investigational Site	Vitrolles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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