Back to resultsEfficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lumiracoxib
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, lumiracoxib, celecoxib, Cox-2
Eligibility Criteria
Inclusion Criteria: Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria). Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy. Exclusion Criteria: Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years. Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib). Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Pharmaceuticals Corporation
Outcomes
Primary Outcome Measures
Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.
Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.
Secondary Outcome Measures
Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
Patient's health status using the Short Form-36 (SF-36), at week 13.
Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00366938
Brief Title
Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).
Official Title
A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, lumiracoxib, celecoxib, Cox-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1464 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lumiracoxib
Primary Outcome Measure Information:
Title
Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
Title
Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.
Title
Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.
Secondary Outcome Measure Information:
Title
Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
Title
Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Title
Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
Title
Patient's health status using the Short Form-36 (SF-36), at week 13.
Title
Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria).
Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.
Exclusion Criteria:
Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Pharmaceuticals Corporation
City
E. Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17266764
Citation
Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable symptom state in a pooled analysis of two multicentre, randomised, double-blind, placebo-controlled studies evaluating lumiracoxib and celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9(1):R11. doi: 10.1186/ar2118.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).
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