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Efficacy and Safety of Lumiracoxib

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

Condition Intervention Phase
Osteoarthritis Drug: Lumiracoxib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Assess the safety and tolerability profile of COX189 in comparison to placebo and celecoxib

Estimated Enrollment: 330
Study Start Date: November 2000
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

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Please refer to this study by its identifier: NCT00267215

Nuernberg, Germany
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00267215     History of Changes
Other Study ID Numbers: CCOX189A2301
Study First Received: December 16, 2005
Last Updated: May 18, 2012

Keywords provided by Novartis:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on September 19, 2017