drugset / Trial / NCT02641561

Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

NCT02641561

Phase 3 Completed 192 enrolled The Cooper Health System
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP. Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis. Despite this, no study to date has evaluated both of these measures for preventing post-ERCP pancreatitis. It is our hope to evaluate the combination of these two modalities for preventing post-ERCP pancreatitis compared with either modality alone.

Timeline

Start
2014-10
Primary completion
2016-06
Completion
2016-06

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Indomethacin Small molecule 100 mg Rectal
Subject Lactated Ringer's Solution Unknown 1 unknown Intravenous
Comparator sodium chloride Unknown Intravenous

Indications