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
1 other identifier
interventional
73
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 13, 2008
CompletedFirst Posted
Study publicly available on registry
August 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
April 19, 2013
CompletedJune 22, 2015
April 1, 2015
3 years
August 13, 2008
November 15, 2012
June 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
48 hours
Secondary Outcomes (2)
Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis
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
7 days
Study Arms (2)
1
ACTIVE COMPARATORaprepitant
2
PLACEBO COMPARATORPlacebo
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- active pancreatitis
- if they are pregnant
- known adverse reaction to aprepitant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Unable to control for pre-procedure dosing
Results Point of Contact
- Title
- Dr. Martin Poleski
- Organization
- DUMC
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Poleski, MD
Duke University Medical Center, Department of Medicine, Division of Gastroenterology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2008
First Posted
August 15, 2008
Study Start
August 1, 2007
Primary Completion
August 1, 2010
Study Completion
November 1, 2012
Last Updated
June 22, 2015
Results First Posted
April 19, 2013
Record last verified: 2015-04