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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
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
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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
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Pfizer Investigational Site, Chaumont 52100, France
Pfizer Investigational Site, Cherbourg 50100, France
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Pfizer Investigational Site, Issy Les Moulineaux 92130, France
Pfizer Investigational Site, Ivry Sur Seine 94200, France
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Pfizer Investigational Site, L'Aigle 61300, France
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Pfizer Investigational Site, La Celle Saint Cloud 78170, France
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Pfizer Investigational Site, Landivisiau 29400, France
Pfizer Investigational Site, Langon 33210, France
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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
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Pfizer Investigational Site, Montgeron 91230, France
Pfizer Investigational Site, Montigny le Bretonneux 78180, France
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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
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Pfizer Investigational Site, Orthez 64300, France
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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
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