A Phase 3 interventional study of TDS-943 (topical diclofenac sodium 4% spray) and celecoxib in Osteoarthritis, sponsored by Mika Pharma GmbH. Completed at 49 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2010-10-13.
Sponsored by Mika Pharma GmbH · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than celecoxib.
This is a multicenter, outpatient, multiple-dose, placebo- and active controlled, double-blind, double-dummy parallel group, randomized (stratified by unilateral vs. bilateral knee OA) trial. The trial will enroll subjects who have been diagnosed with OA of the knee (confirmed by weight-bearing x-ray) and whose condition is in flare at baseline. Subjects who qualify to enter the study will be randomized to topical TDS-943 40 mg bid, oral celecoxib 200 mg qd, or placebo in a 3:2:2 ratio.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 650 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Mika Pharma GmbH is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
placebo
Other: placebo
celecoxib 200 mg qd p.o.
Drug: celecoxib
TDS-943 40 mg bid topically
Drug: TDS-943 (topical diclofenac sodium 4% spray)
Change from baseline in the WOMAC Composite Pain Score
Time frame: 30 days
Change from baseline in the WOMAC Composite Stiffness and Composite Function Scores, Change from Baseline in the Subject's Global Assessment of Arthritic Condition, Change from baseline in the Subject's Assessment of OA Pain, %OMERACT-OARSI responders
Time frame: 30 days
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Mika Pharma GmbH