At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 462 enrolled
Drug / intervention
Indomethacin +4 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.
A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Indomethacin [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy
In Brief
A Phase 3 clinical trial evaluating Indomethacin, Celecoxib, and 1 other intervention for Other Acute Postoperative Pain. Completed, enrolled 462 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
Enrollment StartFeb 2012
First PostedMar 2012
Primary CompletionJun 2012
Study CompletionJul 2012
TodayJul 2026
First PostedMar 5, 2012
Enrollment StartFeb 1, 2012
Primary CompletionJun 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.3 years ago
Interventions
Indomethacindrug
40 mg TID capsules
Indomethacindrug
40 mg BID capsules
Indomethacindrug
20 mg TID capsules
Celecoxibdrug
200 mg capsules
Placebodrug
Capsules