Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)

Study Overview
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Brief Summary
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This 39-week, active controlled, study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2361 study.

Official Title
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A 39-week, Double-blind, Active-controlled Extension to CCOX189A2361, a 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: lumiracoxib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient who completed the core study 2361 may enter the extension trial upon signing informed consent. A patient is defined as completing if he/she completed the core study 2361 up to and including Visit 6 (week 13) without a major protocol violation. Exclusion Criteria: Those patients for whom continued treatment in the extension study is not considered appropriate by the treating physician Those patients who were non-compliant or who demonstrated a major protocol violation in the core study. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lumiracoxib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to: |  |  | 
| Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks. |  |  | 
| Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks. |  |  | 
| Patient's functional status using the WOMAC total score at 26 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib |  |  | 
| To assess the efficacy of lumiracoxib as compared to celecoxib with respect to: |  |  | 
| Overall OA pain intensity on a 0-100 mm VAS by visit |  |  | 
| Patient's global assessment of disease activity by visit |  |  | 
| Physician's global assessment of disease activity by visit |  |  | 
| Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit |  |  | 
| Usage of rescue medication |  |  | 
| Response to treatment according to OARSI criteria by visit |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, lumiracoxib, celecoxib, Cox-2, knee