A Phase 3 interventional study of lumiracoxib in Osteoarthritis, sponsored by Novartis. Completed at 15 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-21.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
This 39-week, active controlled, 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 CCOX189A2361 study.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 1,312 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:
Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks.
Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks.
Patient's functional status using the WOMAC total score at 26 weeks
To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib
To assess the efficacy of lumiracoxib as compared to celecoxib with respect to:
Overall OA pain intensity 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
Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit
Usage of rescue medication
Response to treatment according to OARSI criteria by visit
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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