CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 305 enrolled
Drug / intervention
Diclofenac +2 moredrug
Likely dose
Diclofenac 35 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01461369
NCT01461369Phase 3Completed
CompareCT.gov

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

Iroko Pharmaceuticals, LLC·interventional·Posted Oct 28, 2011·Updated May 26, 2014

In Brief

A Phase 3 clinical trial evaluating Diclofenac and Placebo for Osteoarthritis. Completed, enrolled 305 participants across 40 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2011
Enrollment StartOct 1, 2011
Primary CompletionMar 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.7 years ago

Interventions

Diclofenacdrug

35 mg bid Capsules

Diclofenacdrug

35 mg tid Capsules

Placebodrug

Capsules