CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 428 enrolled
Drug / intervention
Diclofenac Test (lower dose) +3 moredrug
Likely dose
Celecoxib 200 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/NCT01462435
NCT01462435Phase 3Completed

A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy

Iroko Pharmaceuticals, LLC·interventional·Posted Oct 31, 2011·Updated Feb 4, 2014

In Brief

A Phase 3 clinical trial evaluating Diclofenac Test (lower dose), Diclofenac Test (upper dose), and 2 other interventions for Other Acute Postoperative Pain. Completed, enrolled 428 participants across 4 sites.

Detailed Summary

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

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2011
Enrollment StartOct 1, 2011
Primary CompletionFeb 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.7 years ago

Interventions

Diclofenac Test (lower dose)drug

Capsules

Diclofenac Test (upper dose)drug

Capsules

Celecoxibdrug

200 mg Capsules

Placebodrug

Capsules