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Efficacy and Safety of Lumiracoxib

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00267215
First Posted: December 20, 2005
Last Update Posted: May 21, 2012
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.
Information provided by (Responsible Party):
Novartis
  Purpose
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)
  Eligibility

Information from the National Library of Medicine

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

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

  Contacts and Locations
Information from the National Library of Medicine

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): NCT00267215


Locations
Germany
Novartis
Nuernberg, Germany
Sponsors and Collaborators
Novartis
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00267215     History of Changes
Other Study ID Numbers: CCOX189A2301
First Submitted: December 16, 2005
First Posted: December 20, 2005
Last Update Posted: May 21, 2012
Last Verified: May 2012

Keywords provided by Novartis:
Lumiracoxib
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lumiracoxib
Diclofenac
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents