drugset

drugset / Trial / NCT00716547

Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)

NCT00716547 ↗

Phase 3 Completed 1399 enrolled IDEA AG

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.

Timeline

Start: 2008-05
Primary completion: 2009-03
Completion: 2009-05

Publications

Conaghan PG, Dickson J, Bolten W, Cevc G, Rother M. A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology (Oxford). 2013 Jul;52(7):1303-12. doi: 10.1093/rheumatology/ket133. Epub 2013 Mar 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Celecoxib	Other / unclassified	100 mg	Oral
Subject	Ketoprofen	Small molecule	50 mg	Topical
Subject	Ketoprofen	Small molecule	100 mg	Topical

Indications