A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis

NCT02692391 | Completed Phase 3 Results FDA Drug

• 1 other identifier: STUDY19050212
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Acute Pancreatitis

Keywords

Acute pancreatitis; Indomethacin; Organ failure; Prevention

Outcome Measures

Primary Outcomes (2)

• Systemic Inflammatory Response Syndrome (SIRS) Score

  SIRS is a simple clinical score, ranging from 0-4, that utilizes objective, routine clinical parameters (body temperature, heart rate, respiratory rate or arterial carbon dioxide tension and white blood count) that directly reflect the underlying inflammatory response. A lower change in SIRS score (negative number) indicates a better outcome (less inflammation).

  The change in the SIRS score (48 hours - baseline)

• C-Reactive Protein (CRP) Levels.

  CRP levels at 48 hours after enrollment minus CRP levels at enrollment (baseline). A negative number indicates a better outcome (less inflammation).

  48 hours

Secondary Outcomes (2)

• Number of Participants Who Development of Organ Failure

  7 days

• Mortality

  1 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

6 doses, Q8hrs for a total period of 48 hours

Drug: Placebo

Indomethacin suppository

ACTIVE COMPARATOR

Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)

Drug: Indomethacin

Interventions

Indomethacin DRUG

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.

Also known as: Indocin

Indomethacin suppository

Placebo DRUG

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

Also known as: Glycerin

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Univeristy of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• Sotoudehmanesh R, Eloubeidi MA, Asgari AA, Farsinejad M, Khatibian M. A randomized trial of rectal indomethacin and sublingual nitrates to prevent post-ERCP pancreatitis. Am J Gastroenterol. 2014 Jun;109(6):903-9. doi: 10.1038/ajg.2014.9. Epub 2014 Feb 11.

  PMID: 24513806 RESULT

• Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. doi: 10.1016/s0016-5107(04)00353-0. No abstract available.

  PMID: 15173799 RESULT

• Machicado JD, Mounzer R, Paragomi P, Pothoulakis I, Hart PA, Conwell DL, de-Madaria E, Greer P, Yadav D, Whitcomb DC, Lee PJ, Hinton A, Papachristou GI. Rectal Indomethacin Does Not Mitigate the Systemic Inflammatory Response Syndrome in Acute Pancreatitis: A Randomized Trial. Clin Transl Gastroenterol. 2021 Oct 27;12(11):e00415. doi: 10.14309/ctg.0000000000000415.

  PMID: 34704970 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Indomethacin; Glycerol

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Georgios Papachristou, MD PhD
• Organization: Ohio State University

georgios.papachristou@osumc.edu

6142836255

Study Officials

• Georgios I Papachristou, MD PhD

  Ohio State University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 26, 2016
• Study Start: July 1, 2013
• Primary Completion: July 19, 2019
• Study Completion: December 30, 2019
• Last Updated: April 22, 2021
• Results First Posted: April 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)