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Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients

NCT00820612 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2013-02-28

Study results available
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Summary

Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.

Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.

Conditions

  • Post-ERCP Pancreatitis

Interventions

DRUG

Indomethacin

100 mg PR once at the time of ERCP

OTHER

Placebo suppositories

2 placebo suppositories at the time of ERCP

Sponsors & Collaborators

  • Indiana University School of Medicine

    collaborator OTHER

  • University of Kentucky

    collaborator OTHER

  • Case Western Reserve University

    collaborator OTHER

  • University of Michigan

    lead OTHER

Principal Investigators

  • Badih J Elmunzer, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00820612 on ClinicalTrials.gov