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Effect Of Celecoxib On Hip Osteoarthritis (OA) Progression

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: celecoxib (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: 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 outcome: 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

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

Locations and Contacts

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 Ceze 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, Creteil 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, Epernay 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, Joue Les 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 Cedex 53015, France

Pfizer Investigational Site, Le Perreus sur Marne 94000, France

Pfizer Investigational Site, Les Angles 30133, France

Pfizer Investigational Site, Libourne Cedex 333505, France

Pfizer Investigational Site, Limoges 87042, France

Pfizer Investigational Site, Lisieux 14100, France

Pfizer Investigational Site, Lunel 34400, France

Pfizer Investigational Site, Lyon 69007, France

Pfizer Investigational Site, Lyon 69002, France

Pfizer Investigational Site, Lyon 69003, France

Pfizer Investigational Site, Lyon 69006, France

Pfizer Investigational Site, Maisons Alfort 94700, France

Pfizer Investigational Site, Marseille Cedex 05 13354, France

Pfizer Investigational Site, Marseille 13008, France

Pfizer Investigational Site, Marseille 13015, France

Pfizer Investigational Site, Martigues 13500, France

Pfizer Investigational Site, Montgeron 91230, France

Pfizer Investigational Site, Montigny le Bretonneux 78180, France

Pfizer Investigational Site, Montlucon 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, Neufchateau 88300, France

Pfizer Investigational Site, Nevers 58000, France

Pfizer Investigational Site, Nice 06000, France

Pfizer Investigational Site, Nimes 30900, France

Pfizer Investigational Site, Nogent le Rotrou 28400, France

Pfizer Investigational Site, Nosel 77186, France

Pfizer Investigational Site, Obernai 67210, France

Pfizer Investigational Site, Orleans Cedex 01 45000, France

Pfizer Investigational Site, Orleans Cedex 01 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 Cedex 12 75571, France

Pfizer Investigational Site, Paris 75018, France

Pfizer Investigational Site, Paris 75015, France

Pfizer Investigational Site, Paris 75017, France

Pfizer Investigational Site, Paris 75011, France

Pfizer Investigational Site, Paris 75020, France

Pfizer Investigational Site, Petit Quevilly 76140, France

Pfizer Investigational Site, Poitiers 86000, France

Pfizer Investigational Site, Puteaux 92800, France

Pfizer Investigational Site, Pã Ris 75015, 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 Etienne 42000, France

Pfizer Investigational Site, Saint Genevvieve Des Bois 91700, France

Pfizer Investigational Site, Saint Giron 09200, France

Pfizer Investigational Site, Saint Jacques de la Lande 35136, France

Pfizer Investigational Site, Saint Lo 50000, France

Pfizer Investigational Site, Saint Maxime 83120, France

Pfizer Investigational Site, Saint Quentin 02100, France

Pfizer Investigational Site, Sartrouville 78500, France

Pfizer Investigational Site, St. Pierre de Coutances 50200, 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, Vandoeuvre les 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, Vitre 35500, France

Pfizer Investigational Site, Vitrolles 13127, France

Pfizer Investigational Site, Vancouver, British Columbia V5Z 1L7, Canada

Pfizer Investigational Site, 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

Additional Information

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

Starting date: June 2004
Last updated: July 17, 2007

Page last updated: August 23, 2015

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