Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Phase 3 Terminated 449 enrolled Dartmouth-Hitchcock Medical Center

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.

Timeline

Start: 2013-01
Primary completion: 2014-12
Completion: 2014-12

Outcome

Missed primary endpoint

Stopped: “Futility”

registry Indomethacin vs Placebo; p = 0.33; Fisher Exact NCT01774604 ↗

Publications

Background Levenick JM, Gordon SR, Fadden LL, Levy LC, Rockacy MJ, Hyder SM, Lacy BE, Bensen SP, Parr DD, Gardner TB. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology. 2016 Apr;150(4):911-7; quiz e19. doi: 10.1053/j.gastro.2015.12.040. Epub 2016 Jan 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Indomethacin	Small molecule	100 mg	Rectal