A Double-blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis

NACompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2012

Conditions
Pancreatitis
Interventions
DRUG

Indomethacin

Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

DRUG

Placebo suspension

A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.

Trial Locations (1)

06520

Yale New Haven Hospital, New Haven

All Listed Sponsors
lead

Yale University

OTHER

NCT00727740 - A Double-blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis | Biotech Hunter | Biotech Hunter