At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 42 enrolled
Drug / intervention
Indomethacin +1 moredrug
Likely dose
Indomethacin 100 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 Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis
In Brief
A Phase 3 clinical trial evaluating Indomethacin and Placebo for Acute Pancreatitis. Completed, enrolled 42 participants across 1 site.
Detailed Summary
This is a randomized, double-blind, placebo-controlled pilot trial seeking to evaluate the efficacy of rectal indomethacin in abrogating systemic inflammation and subsequently organ failure and mortality in patients with AP and positive SIRS score.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pancreatitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedFeb 2016
Primary CompletionJul 2019
Study CompletionDec 2019
TodayJul 2026
First PostedFeb 26, 2016
Enrollment StartJul 1, 2013
Primary CompletionJul 19, 2019
Study CompletionDec 30, 2019
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 10.3 years ago
Interventions
Indomethacindrug
Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.
Placebodrug
Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin