Double-blind, parallel-group, randomized, study of the efficacy and safety of continuous use of celecoxib vs the usual use” of celecoxib in the treatment of subjects with chronicosteoarthritis of the hip or knee who require an anti-inflammatory medication for control of their pain.
- Conditions
- Osteoarthritis of knee or hip jointMedDRA version: 8.1Level: VTcClassification code 10031161
- Registration Number
- EUCTR2005-004270-25-BE
- Lead Sponsor
- Pfizer S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 812
Subjects with diagnosed, active and symptomatic osteoarthritis of the hip and/or knee must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Subjects, male and female, aged 18-80 years old.
2. Subject has been diagnosed according to the American College of Rheumatology (ACR) guidelines (Appendix D protocol) as having osteoarthritis of the knee or hip joint which the subject identifies as the index joint. Index joint must be in a native, non-prosthetic hip or knee joint.
3. Subjects who, in the opinion of the investigator, may benefit from continuous NSAIDs to control their OA pain.
4. Subjects need to have required NSAIDs to control OA pain within the past 1 month.
5. Subjects must agree to keep physical activity at a stable level throughout the study.
6. Subjects are willing to discontinue their NSAID and experience an OA flare.
7. Subject is mentally and physically capable of performing all study related procedures including IVRS for up to approximately 26 weeks.
8. Subject has access to a touch tone phone to use to contact the IVRS for the duration of the study.
9. If the subject is female and of childbearing potential (including women who have been postmenopausal for less than two years) she must have been using adequate contraception since her last menses and is willing to use adequate contraception during the study, is not lactating, and has had a negative urine pregnancy test at Screening. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of run-in medication. Urine Pregnancy test may be repeated during the study (i.e. additional urine pregnancy tests in between visits) per IRB/EC request or if required by local regulations.
10. Subjects taking up to 325 mg aspirin daily for cardiovascular prophylaxis and who have been on a stable dose for 30 days may be enrolled. Please note – if the subject does take aspirin for cardiovascular prophylaxis they must take the aspirin at least two hours prior to study drug dosingduring the course of the study.
11. Screening flare of the index joint is demonstrated and resolved during the open label run-in with no reoccurrence of flare prior to Visit 3. Refer to Section 7.2 for the Criteria for Confirmation of Screening OA Flare and the Criteria for Resolution of Screening OA Flare.
12. Subjects have signed and dated an informed consent document prior to undergoing any study procedures indicating that they have been informed of all pertinent aspects of the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects presenting with any of the following will not be included in the study:1. History of rheumatoid arthritis.2. History of inflammatory arthritis or gout / pseudo-gout.3. Fibromyalgia Syndrome (FMS).4. Acute joint trauma at Index Joint within the past 3 months with active symptoms.5. Previous or anticipated need for surgical or other invasive procedure performed on index joint during the study6. Subject meets Class IV Criteria for Classification of Functional Capacity (Appendix I Protocol)7. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study8. Subjects have received oral (within 4 weeks), intramuscular (within 2 months), intraarticular (within 3 months) or soft-tissue (within 2 months) injections of corticosteroids, or intra-articular injections of hyaluronic acid in the Index Joint within 9 months of Visit 1 and throughout the duration of the study.9. Subject is currently taking or is anticipated to take any anticoagulants such as clopidogrel (low dose aspirin = 325 mg daily is allowed) or lithium during the course of the study.10. Subject has an active malignancy or history of a malignancy (other then surgically removed basal cell carcinoma or cervical carcinoma in situ) within 5 years prior to enrollment in study.11. Subject has been diagnosed or treated for esophageal, gastric, pyloric channel or duodenal ulceration within 60 days prior to the first dose of study medication.12. Subject has a history of GI perforations, obstructions, or gastrointestinal bleeding.13. Subjects with active GI disease (e.g. inflammatory bowel disease or active peptic ulceration), a chronic or acute renal or hepatic disorder, and or a significant coagulation defect.14. Subjects with laboratory screening >1.5 ULN for SGOT, SGPT, estimated creatinine clearance less then 30 mL/min or other clinically significant lab abnormalities within 14 days of the Screening Visit.15. Subjects with known sensitivity to COX-2 specific inhibitors, paracetamol/acetaminophen, sulfonamides, aspirin, NSAIDS, or related compounds.16. Subjects on glucosamine and / or chondroitin sulfate are excluded unless they have been on a stable dose for greater than four months, or have discontinued these medications for at least four months.17. Subject has previously been screened for this study.18. Subject has symptoms, signs or treatment for congestive heart failure (NYHA Classification II-IV, Appendix H Protocol) or known left ventricular dysfunction with ejection fraction < 40%.19. The subject has established ischaemic heart disease and/or cerebrovascular disease.20. The subject has planned revascularization (PCI or CABG) at the time of study screening.21. The subject has atrial fibrillation or flutter, severe ventricular arrhythmias, or implantable cardioverter defibrillator (ICD).22. The subject has peripheral arterial disease.23. The subject has an unstable condition defined as any of the following:·Angina at rest or uncontrolled angina·Hospitalization or emergency department visits for cardiac-related illness in the previous 3 months.·Uncontrolled hypertension (defined as systolic BP >160 mmHg and/or diastolic BP >95 mmHg at the baseline visit).·The subject has undergone coronary by-pass surgery or any major surgery (cardiac or non-cardiac) or trauma within the previous 9 months.24. Other acute or chronic medical
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether continuous use over a 6-month period of celecoxib 200 mg per day is more effective than intermittent use of celecoxib 200 mg per day in preventing spontaneous OA flares.;Secondary Objective: 1. To evaluate the safety and tolerability of continuous use over a 6-month period of celecoxib 200 mg QD versus usual use” celecoxib 200 mg QD.<br>2. To demonstrate whether disease management of OA as assessed by measures of pain and function is more effective using a regimen of celecoxib 200 mg QD continuous use over a 6-month period versus usual use” celecoxib 200 mg QD.;Primary end point(s): The primary endpoint for this study is the number of OA flares of the hip or knee joint which meet ACR criteria for OA from the first dose of study medication at the beginning of randomization to the last dose of study medication taken during Period III. OA flare is defined in Section 7.2 of Protocol.
- Secondary Outcome Measures
Name Time Method