Back to resultsEfficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis(OA)
Primary Purpose
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 Osteoarthritis focused on measuring Osteoarthritis, lumiracoxib, celecoxib, Cox-2, knee
Eligibility Criteria
Inclusion Criteria:
- Have completed the core CCOX189A2360 study
- Males and females over the 18 years old
Exclusion Criteria:
- Treatment in the extension study is not considered appropriate by the treating physician
- Non-compliance or major protocol violation of the core study
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
Outcomes
Primary Outcome Measures
To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.
Secondary Outcome Measures
Overall OA pain intensity (Target knee) on a 0-100 mm VAS by visit
Patient's global assessment of disease activity by visit
Physician's global assessment of disease activity by visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00475800
Brief Title
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis(OA)
Official Title
A 39-week, Open-label Extension to CCOX189A2360, 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
January 2004 (undefined)
Primary Completion Date
December 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 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, lumiracoxib, celecoxib, Cox-2, knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
833 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lumiracoxib
Primary Outcome Measure Information:
Title
To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.
Secondary Outcome Measure Information:
Title
Overall OA pain intensity (Target knee) on a 0-100 mm VAS by visit
Title
Patient's global assessment of disease activity by visit
Title
Physician's global assessment of disease activity by visit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Have completed the core CCOX189A2360 study
Males and females over the 18 years old
Exclusion Criteria:
Treatment in the extension study is not considered appropriate by the treating physician
Non-compliance or major protocol violation of the core study
Other protocol-defined inclusion/exclusion criteria may apply
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
City
Brooklyn Park
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Novartis Investigative Site
City
Brampton
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis(OA)
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