Clinical Trials Directory

Trials / Completed

CompletedNCT01461369

Study of Diclofenac Capsules to Treat Osteoarthritis Pain

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
305 (actual)
Sponsor
Iroko Pharmaceuticals, LLC · Industry
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDiclofenac35 mg bid Capsules
DRUGDiclofenac35 mg tid Capsules
DRUGPlaceboCapsules

Timeline

Start date
2011-10-01
Primary completion
2012-03-01
Completion
2012-10-01
First posted
2011-10-28
Last updated
2014-05-26
Results posted
2014-05-26

Locations

40 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01461369. Inclusion in this directory is not an endorsement.