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A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis

NCT02692391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-04-22

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled pilot trial seeking to evaluate the efficacy of rectal indomethacin in abrogating systemic inflammation and subsequently organ failure and mortality in patients with AP and positive SIRS score.

Conditions

Interventions

DRUG

Indomethacin

Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.

DRUG

Placebo

Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Georgios I Papachristou, MD PhD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2019-07-19
Completion
2019-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02692391 on ClinicalTrials.gov