Back to resultsEfficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
Primary Purpose
Osteoarthritis, Hip
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lumiracoxib (drug)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Osteoarthritis, Hip, Lumiracoxib, Efficacy, Safety
Eligibility 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.
Sites / Locations
- For US Site Information, contact Novartis Pharmaceuticals
- Various Sites
- Various Sites
- Various Sites
- Various Sites
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00154219
Brief Title
Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. 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]).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
Osteoarthritis, Hip, Lumiracoxib, Efficacy, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lumiracoxib (drug)
Primary Outcome Measure Information:
Title
WOMAC 3.1 LK questionnaire after 13 weeks of treatment
Title
Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
Secondary Outcome Measure Information:
Title
Overall OA pain intensity (VAS)by visit
Title
Physician's global assessment of disease activity (VAS) by visit
Title
Response to treatment according to OARSI criteria by visit
Title
Actual OA pain intensity at 12 hours post-dose by visit
Title
Number of rescue tablets taken during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
For US Site Information, contact Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Facility Name
Various Sites
City
Multiple Cities
Country
Canada
Facility Name
Various Sites
City
Multiple Cities
Country
Germany
Facility Name
Various Sites
City
Multiple Cities
Country
Italy
Facility Name
Various Sites
City
Multiple Cities
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21607551
Citation
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.
Results Reference
derived
Links:
URL
http://www.osteoarthritistrial.com/
Description
Novartis patient recruitment website
Learn more about this trial
Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
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