CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,037 enrolled
Drug / intervention
high dose indomethacin +1 moredrug
Likely dose
high dose indomethacin 200mgfrom 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/NCT01912716
NCT01912716Phase 3Completed

Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients: Searching for the Optimal Dose. A Prospective, Randomized Trial

Indiana University·interventional·Posted Jul 31, 2013·Updated Jul 5, 2019

In Brief

A Phase 3 clinical trial evaluating high dose indomethacin and standard dose indomethacin for Post-ERCP Pancreatitis. Completed, enrolled 1,037 participants across 6 sites.

Detailed Summary

It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of 100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients. However, the optimal dose required is not known. The purpose of this study is to determine whether a dose of 200 mg, administered as rectal suppositories, is more effective than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted tube with a camera is passed down the patient's throat and allows for evaluation of the bile duct and/or pancreatic duct. The most common side effect of this procedure is post-ERCP pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this complication than others. Our hypothesis is to compare the efficacy of these two dose regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the frequency and severity of post-ERCP pancreatitis in high-risk patients.

Study Details

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 31, 2013
Enrollment StartJul 1, 2013
Primary CompletionApr 1, 2018
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.9 years ago

Interventions

high dose indomethacindrug

patients randomized to this intervention receive 200mg indomethacin

standard dose indomethacindrug

patients randomized to this intervention receive 100mg indomethacin