Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Phase 3 Completed 305 enrolled Iroko Pharmaceuticals, LLC

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.

Timeline

Start: 2011-10
Primary completion: 2012-03
Completion: 2012-10

Outcome

Mixed primary results

registry Diclofenac 35 mg Three Times Daily vs Placebo; p = 0.0024; Difference in Least Squares Mean -11.68 (95% CI -19.17 to -4.19) NCT01461369 ↗

registry Diclofenac 35 mg Two Times Daily vs Placebo; p = 0.0795; Difference in Least Squares Mean -6.58 (95% CI -13.94 to 0.78) NCT01461369 ↗

Publications

Gibofsky A, Hochberg MC, Jaros MJ, Young CL. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Curr Med Res Opin. 2014 Sep;30(9):1883-93. doi: 10.1185/03007995.2014.946123. Epub 2014 Aug 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diclofenac	Other / unclassified	35 mg	—