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

History of Changes

Tracking Information
First Received Date ^ICMJE	December 16, 2005
Last Updated Date	May 18, 2012
Start Date ^ICMJE	November 2000
Primary Completion Date	February 2001 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 28, 2006)	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
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00267215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 28, 2006)	Assess the safety and tolerability profile of COX189 in comparison to placebo and celecoxib
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Lumiracoxib
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Osteoarthritis
Intervention ^ICMJE	Drug: Lumiracoxib
Study Arm (s)	Not Provided
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	330
Completion Date	Not Provided
Primary Completion Date	February 2001 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00267215
Other Study ID Numbers ^ICMJE	CCOX189A2301
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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