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Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).

This study has been completed.
Information provided by:
Novartis Identifier:
First received: August 18, 2006
Last updated: May 18, 2012
Last verified: May 2012
This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).

Condition Intervention Phase
Osteoarthritis, Knee
Drug: Lumiracoxib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
  • Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.
  • Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.

Secondary Outcome Measures:
  • Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
  • Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
  • Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
  • Patient's health status using the Short Form-36 (SF-36), at week 13.
  • Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.

Estimated Enrollment: 1464
Study Start Date: September 2003
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria).
  • Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.

Exclusion Criteria:

  • Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
  • Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).

Other protocol-defined inclusion/exclusion criteria may apply.

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Please refer to this study by its identifier: NCT00366938

United States, New Jersey
Novartis Pharmaceuticals Corporation
E. Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Study Chair: Novartis Pharmaceuticals Novartis
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00366938     History of Changes
Other Study ID Numbers: CCOX189A2360
Study First Received: August 18, 2006
Last Updated: May 18, 2012

Keywords provided by Novartis:
Osteoarthritis, lumiracoxib, celecoxib, Cox-2

Additional relevant MeSH terms:
Osteoarthritis, Knee
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 April 28, 2017