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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,312
Novartis Investigative Site
Malvern, Australia
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Prague, Czechia
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
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Novartis Investigative Site
Turku, Finland
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Haifa, Israel
Novartis Investigative Site
Lisse, Netherlands
Novartis Investigative Site
Rotorua, New Zealand
Novartis Investigative Site
Poznan, Poland
...and 5 more locations