Efficacy and Safety of Lumiracoxib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00267215
First received: December 16, 2005
Last updated: May 18, 2012
Last verified: May 2012

December 16, 2005
May 18, 2012
November 2000
February 2001   (final data collection date for primary outcome measure)
Assess the short-term (3-5 hours) analgesic efficacy of COX189, 400mg administered once a day for 7 days, compared to placebo and to 200mg celecoxib bid
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Complete list of historical versions of study NCT00267215 on ClinicalTrials.gov Archive Site
Assess the safety and tolerability profile of COX189 in comparison to placebo and celecoxib
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Efficacy and Safety of Lumiracoxib
A One-week Multicenter, Multiple-dose, Randomized, Double-blind, Double-dummy, Parallel-group Comparison of the Analgesic Efficacy and Safety of Lumiracoxib (COX189), Celecoxib, and Placebo in the Treatment of Osteoarthritis of the Knee

This trial assessed the safety and efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to a single dose of celecoxib 200mg. It also assessed safety and efficacy of 400mg lumiracoxib administered once a day for 7 days compared to placebo and to 200 mg celecoxib twice daily.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoarthritis
Drug: Lumiracoxib
Not Provided
Wittenberg RH, Schell E, Krehan G, Maeumbaed R, Runge H, Schluter P, Fashola TO, Thurston HJ, Burger KJ, Trechsel U. First-dose analgesic effect of the cyclo-oxygenase-2 selective inhibitor lumiracoxib in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled comparison with celecoxib [NCT00267215]. Arthritis Res Ther. 2006;8(2):R35. Epub 2006 Jan 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
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February 2001   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Osteoarthritis of the knee
  • Pain intensity at baseline of at least 50mm on a 100mm visual analog scale

Other protocol-defined inclusion/exclusion criteria may apply

Both
50 Years and older
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Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00267215
CCOX189A2301
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Novartis
Novartis
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Not Provided
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP