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

Primary Purpose

Pancreatitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

aprepitant

Placebo

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring pancreatitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

aprepitant

Placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis

Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis

Full Information

NCT ID

NCT00736073

First Posted

August 13, 2008

Last Updated

June 18, 2015

Sponsor

Duke University

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00736073

Brief Title

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

Official Title

A Randomized, Double-Blind, Prospective Trial of Oral Administration of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatitis

Keywords

pancreatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

aprepitant

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

aprepitant

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Poleski, MD

Organizational Affiliation

Duke University Medical Center, Department of Medicine, Division of Gastroenterology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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