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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
Awards & highlights

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 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
1%
Vascular rupture
1%
Drug eruption
1%
Gingival bleeding
1%
Application site pruritis
1%
Inflammation
1%
Upper respiratory tract infections
1%
Nasopharyngitis
1%
Ligament sprain
1%
Pruritis
1%
Rash
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,418 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,864 Total Patients Enrolled
Santhi Vege, MDPrincipal InvestigatorMayo Clinic
~5 spots leftby Sep 2025
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