Phase 3
Completed N=42
A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis
Source: ClinicalTrials.gov NCT02692391 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Systemic Inflammatory Response Syndrome (SIRS) Score — -0.96; -1 score on a scale — p=0.87
◆ Published Evidence
Highly cited
466citations · ~21 / year
Prevention of post-ERCP pancreatitis: a comprehensive review.
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.
Linked Publications (3)
-
Prevention of post-ERCP pancreatitis: a comprehensive review.
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A randomized trial of rectal indomethacin and sublingual nitrates to prevent post-ERCP pancreatitis.
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Rectal Indomethacin Does Not Mitigate the Systemic Inflammatory Response Syndrome in Acute Pancreatitis: A Randomized Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systemic Inflammatory Response Syndrome (SIRS) Score |
-0.96; -1 | 0.87 |
| PRIMARY C-Reactive Protein (CRP) Levels. |
-1.43; -2.08 | 0.48 |
| SECONDARY Number of Participants Who Development of Organ Failure |
6; 3 | 0.71 |
| SECONDARY Mortality |
1; 0 | 1.00 |
Eligibility Criteria
Inclusion Criteria
- 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 38°C, heart rate >90/min, respiratory rate >20/min OR PaCO2 12,000/mm3 or >10% bands) upon hospital admission or who develop SIRS during their first week of hospitalization
Exclusion Criteria
- Presence of OF (shock defined by SBP 1.5mg/dL)
- Active peptic ulcer disease
- Pregnancy
- Use of daily NSAIDs within 1 week of presentation
- Allergy to NSAIDs.
Data sourced from ClinicalTrials.gov (NCT02692391) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.