drugset
drugset / Trial / NCT00546832

Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II

NCT00546832 ↗

Phase 3 Completed 650 enrolled Mika Pharma GmbH
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2007-10
Primary completion
2008-10
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 200 mg Oral
Subject Diclofenac Other / unclassified 40 mg Topical

Indications

osteoarthritis, knee