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Nonsteroidal Anti-inflammatory Drug

Indomethacin for Chronic Pancreatitis

Phase 1 & 2

Waitlist Available

Led By Santhi Vege, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 28 days

Summary

This trial aims to find ways to slow down the progression of chronic pancreatitis and explore treatment options. It focuses on patients suffering from this condition, which can cause severe pain and complications. The specific methods and how they work are not detailed in the summary.

Eligible Conditions

Chronic Pancreatitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Prostaglandin E2 (PGE2) Concentrations

Secondary study objectives

Change in Pain Composite Score

Change in Quality of Life (Mental Health)

Change in Quality of Life (Physical Health)

+1 more

Side effects data

From 2014 Phase 4 trial • 270 Patients • NCT01957215

Vascular rupture

Drug eruption

Gingival bleeding

Application site pruritis

Inflammation

Upper respiratory tract infections

Nasopharyngitis

Ligament sprain

Pruritis

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Indomethacin Patch

Placebo Patch

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IndomethacinExperimental Treatment2 Interventions

The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.

Group II: PlaceboPlacebo Group2 Interventions

Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endoscopy for Pancreatic Function Testing

2020

Completed Phase 2

~30

Indomethacin

2011

Completed Phase 4

~5790