Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00366938|
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : May 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Drug: Lumiracoxib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1464 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||September 2003|
|Primary Completion Date :||March 2004|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366938
|United States, New Jersey|
|Novartis Pharmaceuticals Corporation|
|E. Hanover, New Jersey, United States, 07936|
|Study Chair:||Novartis Pharmaceuticals||Novartis|