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
1 other identifier
interventional
330
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 16, 2005
CompletedFirst Posted
Study publicly available on registry
December 20, 2005
CompletedMay 21, 2012
May 1, 2012
3 months
December 16, 2005
May 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Assess the safety and tolerability profile of COX189 in comparison to placebo and celecoxib
Interventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis of the knee
- Pain intensity at baseline of at least 50mm on a 100mm visual analog scale
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis
Nuremberg, Germany
Related Publications (1)
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. doi: 10.1186/ar1854. Epub 2006 Jan 16.
PMID: 16469112DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2005
First Posted
December 20, 2005
Study Start
November 1, 2000
Primary Completion
February 1, 2001
Last Updated
May 21, 2012
Record last verified: 2012-05