Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

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

Condition Intervention Phase
Knee Osteoarthritis
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 on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks.
  • Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks.
  • Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.

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: 1684
Study Start Date: September 2003
Primary Completion Date: February 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 peptic 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00367315

Nuernberg, Germany
Basel, Switzerland
Sponsors and Collaborators
Study Chair: Novartis Pharmaceuticals Novartis
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00367315     History of Changes
Other Study ID Numbers: CCOX189A2361
Study First Received: August 18, 2006
Last Updated: May 18, 2012

Keywords provided by Novartis:
Osteoarthritis, lumiracoxib, celecoxib, cyclooxygenase-2 inhibitors

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 May 25, 2017