COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT00475800
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : May 21, 2012
Information provided by (Responsible Party):

Brief Summary:
This 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Lumiracoxib Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 833 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 39-week, Open-label Extension to CCOX189A2360, 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
Study Start Date : January 2004
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  1. To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.

Secondary Outcome Measures :
  1. Overall OA pain intensity (Target knee) on a 0-100 mm VAS by visit
  2. Patient's global assessment of disease activity by visit
  3. Physician's global assessment of disease activity by visit.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Have completed the core CCOX189A2360 study
  • Males and females over the 18 years old

Exclusion Criteria:

  • Treatment in the extension study is not considered appropriate by the treating physician
  • Non-compliance or major protocol violation of the core study

Other protocol-defined inclusion/exclusion criteria may apply

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 identifier (NCT number): NCT00475800

Layout table for location information
United States, Arizona
Tucson, Arizona, United States, 85723
United States, Minnesota
Brooklyn Park, Minnesota, United States, 55430
United States, New Mexico
Albuquerque, New Mexico, United States, 87109
United States, South Dakota
Sioux Falls, South Dakota, United States, 57105
United States, Texas
San Antonio, Texas, United States, 78232
Canada, Ontario
Novartis Investigative Site
Brampton, Ontario, Canada
Sponsors and Collaborators
Layout table for additonal information
Responsible Party: Novartis Identifier: NCT00475800    
Other Study ID Numbers: CCOX189A2360E1
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012
Keywords provided by Novartis:
Additional relevant MeSH terms:
Layout table for 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