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

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

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Primary Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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.

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): NCT00154219


Locations
United States, New Jersey
For US Site Information, contact Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Canada
Various Sites
Multiple Cities, Canada
Germany
Various Sites
Multiple Cities, Germany
Italy
Various Sites
Multiple Cities, Italy
United Kingdom
Various Sites
Multiple Cities, United Kingdom
Sponsors and Collaborators
Novartis
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00154219     History of Changes
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:
Osteoarthritis
Osteoarthritis, Hip
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