Back to resultsEfficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lumiracoxib
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, lumiracoxib, celecoxib, cyclooxygenase-2 inhibitors
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 peptic 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
- Novartis
Outcomes
Primary Outcome Measures
Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks.
Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks.
Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.
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
NCT00367315
Brief Title
Efficacy and Safety of Lumiracoxib in Patients With Primary 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
February 2004 (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
This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, lumiracoxib, celecoxib, cyclooxygenase-2 inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1684 (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 on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks.
Title
Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks.
Title
Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.
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 peptic 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
City
Nuernberg
Country
Germany
Facility Name
Novartis
City
Basel
Country
Switzerland
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 Primary Knee Osteoarthritis (OA)
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