CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 373 enrolled
Drug / intervention
Indomethacin +3 moredrug
Likely dose
Indomethacin 40 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/NCT01626118
NCT01626118Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Indomethacin Nanoformulation Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy

Iroko Pharmaceuticals, LLC·interventional·Posted Jun 22, 2012·Updated Mar 17, 2014

In Brief

A Phase 3 clinical trial evaluating Indomethacin and Placebo for Other Acute Postoperative Pain. Completed, enrolled 373 participants across 4 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOther Acute Postoperative Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2012
Enrollment StartMay 1, 2012
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.0 years ago

Interventions

Indomethacindrug

capsules, 40 mg, TID

Indomethacindrug

capsules, 40 mg, BID

Indomethacindrug

capsules, 20 mg, TID

Placebodrug

capsules