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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00154219
First received: September 7, 2005
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Osteoarthritis, Hip
Drug: Lumiracoxib (drug)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

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

Estimated Enrollment: 1200
Study Start Date: November 2004
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided by Novartis

Additional 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
Study First Received: September 7, 2005
Last Updated: May 18, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: The Italian Medicines Agency

Keywords provided by Novartis:
Osteoarthritis, Hip, Lumiracoxib, Efficacy, Safety

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lumiracoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014