Working… Menu

Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis

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: NCT00154219
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 21, 2012
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs]).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Drug: Lumiracoxib (drug) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoarthritis Using Celecoxib (200 mg o.d.) as a Positive Control
Study Start Date : November 2004
Actual Primary Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  1. WOMAC 3.1 LK questionnaire after 13 weeks of treatment
  2. Patient's global assessment of disease activity (VAS) after 13 weeks of treatment

Secondary Outcome Measures :
  1. Overall OA pain intensity (VAS)by visit
  2. Physician's global assessment of disease activity (VAS) by visit
  3. Response to treatment according to OARSI criteria by visit
  4. Actual OA pain intensity at 12 hours post-dose by visit
  5. Number of rescue tablets taken during the study

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:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of primary hip osteoarthritis
  • Qualifying pain intensity in the hip joint
  • Requiring NSAID therapy

Exclusion Criteria:

  • Rheumatoid arthritis or other inflammatory joint disease
  • Disease or disorder that may interfere with pain assessment of the hip
  • Open knee/hip surgery within the last year
  • Past history of heart attack, stroke or angina (chest pain)
  • Liver disorder
  • History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment

Other protocol-defined 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): NCT00154219

Layout table for location information
United States, New Jersey
For US Site Information, contact Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Various Sites
Multiple Cities, Canada
Various Sites
Multiple Cities, Germany
Various Sites
Multiple Cities, Italy
United Kingdom
Various Sites
Multiple Cities, United Kingdom
Sponsors and Collaborators
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis Identifier: NCT00154219    
Other Study ID Numbers: CCOX189A2367
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012
Keywords provided by Novartis:
Osteoarthritis, Hip, Lumiracoxib, Efficacy, Safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Hip
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