A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
The purpose of this study is to determine if giving Aprepitant 4 hours before and for two days after ERCP decreases the risk of developing pancreatitis after ERCP.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Prospective Trial of Oral Administration of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis|
- Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control). [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis [ Time Frame: 1 week ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||November 2012|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose
Placebo Comparator: 2
one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose
This study involves taking a drug Aprepitant by mouth 4 hours before the ERCP and once a day for two days after the ERCP, in an attempt to reduce the risk of pancreatitis caused by ERCP. Pancreatitis, or injury and inflammation of the pancreas, is the most common complication of ERCP and occurs in approximately 6 out of every 100 patients undergoing ERCP. It may result in pain and lead to hospitalization and, in some cases, a need for further procedures such as surgery.
Aprepitant is a medication that is currently used to prevent nausea and vomiting in some patients caused by chemotherapy for the treatment of cancer. It is also approved for the prevention of post-operative nausea and vomiting. There is theoretical evidence from animal studies that the way in which Aprepitant works in the body may prevent pancreatitis.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Martin Poleski, MD||Duke University Medical Center, Department of Medicine, Division of Gastroenterology|