A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Pancreatitis

In brief

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.

Key facts

Study ID

NCT02692391

Run by

University of Pittsburgh

People needed

42

Starts

2013-07-01

Expected to finish

2019-12-30

Last updated by the study team

2021-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients ages 18 or above admitted to UPMC with a diagnosis of AP based on at least 2 of the following criteria:
• (i) abdominal pain characteristic of AP (ii) serum amylase and/or lipase ≥ 3 times the upper limit of normal (iii) characteristic findings of AP on abdominal CT scan will be screened for study enrollment.
• Patients with SIRS (≥ 2 of the following criteria: temperature <36°C or >38°C, heart rate >90/min, respiratory rate >20/min OR PaCO2<32 mmHg, WBC <4,000/mm3, >12,000/mm3 or >10% bands) upon hospital admission or who develop SIRS during their first week of hospitalization

You may not qualify if…

• Presence of OF (shock defined by SBP<90mmHg, PO2<60mmHg on room air or need for mechanical ventilation, Cr≥2mg/dL)
• Presence of renal dysfunction (Cr>1.5mg/dL)
• Active peptic ulcer disease
• Pregnancy
• Use of daily NSAIDs within 1 week of presentation
• Allergy to NSAIDs.

Where it is running

• Univeristy of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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