Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
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
1 other identifier
interventional
1,200
5 countries
5
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 \[NSAIDs\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedMay 21, 2012
May 1, 2012
1.9 years
September 7, 2005
May 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
WOMAC 3.1 LK questionnaire after 13 weeks of treatment
Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of primary hip osteoarthritis
- Qualifying pain intensity in the hip joint
- Requiring NSAID therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (5)
For US Site Information, contact Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Various Sites
Multiple Cities, Canada
Various Sites
Multiple Cities, Germany
Various Sites
Multiple Cities, Italy
Various Sites
Multiple Cities, United Kingdom
Related Publications (1)
Schnitzer TJ, Dattani ID, Seriolo B, Schneider H, Moore A, Tseng L, Sallstig P, Rebuli R, Maxwell T. A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis. Clin Rheumatol. 2011 Nov;30(11):1433-46. doi: 10.1007/s10067-011-1776-4. Epub 2011 May 24.
PMID: 21607551DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
November 1, 2004
Primary Completion
October 1, 2006
Last Updated
May 21, 2012
Record last verified: 2012-05