NCT0014530152 Week, International, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability & Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid & Celecoxib 200 mg od in Pts With Primary OA of Hip, Knee, Hand or SpineOsteoarthritis
52 Week, International, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability & Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid & Celecoxib 200 mg od in Pts With Primary OA of Hip, Knee, Hand or Spine
WOMAC 3.1 LK questionnaire after 13 weeks of treatment
Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
Assess safety and tolerability profile of lumiracoxib in comparison to baseline
To show that either regimen of lumiracoxib (100mg od or 100mg bid) is not inferior to celecoxib 200mg od with respect to retention rate at 1 year in pts suffering from primary OA in hip, knee, hand or spine.
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.
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
Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.
Assess the short-term (3-5 hours) analgesic efficacy of COX189, 400mg administered once a day for 7 days, compared to placebo and to 200mg celecoxib bid
Secondary Endpoints
Overall OA pain intensity (VAS)by visit
Physician's global assessment of disease activity (VAS) by visit
Response to treatment according to OARSI criteria by visit
Inclusion Criteria:
* Diagnosis of primary hip osteoarthritis
* Qualifying pain intensity in the hip joint
* Requiring NSAID therapy
Exclusion Criteria:
* Rheumatoid arthritis or other inflammatory joint disease
* Disease or disorder that may interfere with pain assessment of the hip
* Open knee/...
Lumiracoxib is an investigational small molecule being studied for the treatment of osteoarthritis, including osteoarthritis of the hip and knee. It is being developed by Novartis AG (NVS) and has completed Phase 3 clinical trials for these indications.
How does Lumiracoxib work?
Lumiracoxib is a small molecule developed for osteoarthritis. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not described here.
Who makes Lumiracoxib?
Lumiracoxib is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis has sponsored multiple Phase 3 clinical trials evaluating the drug for osteoarthritis.
What phase is Lumiracoxib in?
Lumiracoxib is in Phase 3 clinical development. Five Phase 3 trials have been completed, with a total enrollment of 5,646 participants. The drug is investigational and has not been reported as approved by regulatory authorities.
What clinical trials is Lumiracoxib in?
Lumiracoxib has completed five Phase 3 trials, including NCT00145301, NCT00267215, NCT00475800, and NCT00476034. These trials evaluated the drug in patients with osteoarthritis, including knee osteoarthritis, across multiple countries such as Germany, the United States, and Canada.
Is Lumiracoxib the same as Prexige?
Lumiracoxib is not reported to have any alternative names in the available information. The drug is being developed by Novartis AG under the name Lumiracoxib for the treatment of osteoarthritis.