Status:
COMPLETED
52 Week, International, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability & Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid & Celecoxib 200 mg od in Pts With Primary OA of Hip, Knee, Hand or Spine
Lead Sponsor:
Novartis
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This trial will compare the retention on treatment (based on the rate of patients staying on treatment for 1 year) of patients suffering from primary osteoarthritis using two different doses of lumira...
Eligibility Criteria
Inclusion
- Primary osteoarthritis in the hip, knee, hand, or spine
- Requiring NSAID therapy
Exclusion
- Secondary OA with history and/ or any evidence of the following diseases: rheumatoid arthritis, uncontrolled gout, inflammatory joint disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders (e.g. hypermobility), collagen gene mutations, primary fibromyalgia (secondary fibromyalgia is allowed if in the opinion of the investigator it will not interfere with the patient's OA pain assessment), and systemic lupus erythematosus
- History and/ or any evidence of the following diseases in the target joint: septic arthritis, gout, recurrent episodes of pseudogout, Paget's disease of the bone, and articular fracture. If the patient has history of these conditions, then patient should only be excluded if the target joint is affected.
- History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
3036 Patients enrolled
Trial Details
Trial ID
NCT00145301
Start Date
September 1 2004
Last Update
May 21 2012
Active Locations (1)
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1
Novartis
Nuremberg, Germany