Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).
This study has been completed.
Information provided by:
First received: August 18, 2006
Last updated: May 18, 2012
Last verified: May 2012
This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
- Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.
- Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.
Secondary Outcome Measures:
- Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
- Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
- Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
- Patient's health status using the Short Form-36 (SF-36), at week 13.
- Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
|Study Start Date:||September 2003|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
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