Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00154219
First received: September 7, 2005
Last updated: May 18, 2012
Last verified: May 2012
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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
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 Diclofenac Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 13, 2013