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
Sponsor study identifier
interventional
833
2 countries
6
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2004
Actual (reported)Study Completion
Not reported
Date not reportedThis 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
December 2004
Actual (reported)May 18, 2007
Actual (reported)May 21, 2007
Actual (reported)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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Tucson, Arizona, 85723, United States
Brooklyn Park, Minnesota, 55430, United States
Albuquerque, New Mexico, 87109, United States
Sioux Falls, South Dakota, 57105, United States
San Antonio, Texas, 78232, United States
Novartis Investigative Site
Brampton, Ontario, Canada
833 participants (actual enrollment reported by the registry).
First Submitted
May 18, 2007
First Posted
May 21, 2007
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2004
Actual (reported)Last Updated
May 21, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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