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A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00736073
First Posted: August 15, 2008
Last Update Posted: June 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Duke University
August 13, 2008
August 15, 2008
November 15, 2012
April 19, 2013
June 22, 2015
August 2007
August 2010   (Final data collection date for primary outcome measure)
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 ]
Determine and compare the rates of post-ERCP pancreatitis in patients who are administered aprepitant and placebo prior to ERCP and one day after ERCP:Assess the total number of cases of post-ERCP pancreatitis in each group (treatment and control). [ Time Frame: 48 hours ]
Complete list of historical versions of study NCT00736073 on ClinicalTrials.gov Archive Site
  • Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis [ Time Frame: 48 hours post ERCP and 1 week post ERCP ]
  • Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis [ Time Frame: 7 days ]
Assess incidence of pain post-ERCP, within 48 hours of ERCP, and at 1 week post-ERCP; unrelated to pancreatitis [ Time Frame: 1 week ]
Not Provided
Not Provided
 
A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
A Randomized, Double-Blind, Prospective Trial of Oral Administration 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pancreatitis
  • Drug: aprepitant
    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
  • Drug: Placebo
    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
  • Active Comparator: 1
    aprepitant
    Intervention: Drug: aprepitant
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
November 2012
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria: Patients selected for the study will be those undergoing ERCP who are at high risk for development of post-ERCP pancreatitis

  • patients expected to undergo a sphincterotomy
  • patients with suspected sphincter of oddi dysfunction
  • patients with a known history in the past of post-ERCP pancreatitis
  • patients less than 60 years of age

Exclusion Criteria:

  • active pancreatitis
  • if they are pregnant
  • known adverse reaction to aprepitant
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00736073
Pro00005149
No
Not Provided
Not Provided
Duke University
Duke University
Merck Sharp & Dohme Corp.
Principal Investigator: Martin Poleski, MD Duke University Medical Center, Department of Medicine, Division of Gastroenterology
Duke University
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP