Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis(OA)
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
1 other identifier
interventional
833
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 18, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedMay 21, 2012
May 1, 2012
11 months
May 18, 2007
May 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Have completed the core CCOX189A2360 study
- Males and females over the 18 years old
You may not qualify if:
- Treatment in the extension study is not considered appropriate by the treating physician
- Non-compliance or major protocol violation of the core study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (6)
Unknown Facility
Tucson, Arizona, 85723, United States
Unknown Facility
Brooklyn Park, Minnesota, 55430, United States
Unknown Facility
Albuquerque, New Mexico, 87109, United States
Unknown Facility
Sioux Falls, South Dakota, 57105, United States
Unknown Facility
San Antonio, Texas, 78232, United States
Novartis Investigative Site
Brampton, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2007
First Posted
May 21, 2007
Study Start
January 1, 2004
Primary Completion
December 1, 2004
Last Updated
May 21, 2012
Record last verified: 2012-05