CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Indomethacin +2 moredrug
Likely dose
Indomethacin 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04207060
NCT04207060Phase 2Completed

Phase 1/2 Trial of Indomethacin in Chronic Pancreatitis (The PAIR Trial)

Mayo Clinic·interventional·Posted Dec 20, 2019·Updated Sep 4, 2024

In Brief

A Phase 2 clinical trial evaluating Indomethacin, Placebo, and 1 other intervention for Chronic Pancreatitis. Completed, enrolled 27 participants across 2 sites.

Detailed Summary

The researchers are trying to find a way to slow down the progression of chronic pancreatitis (CP) and investigate the possibility of the long term treatment of this disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 20, 2019
Enrollment StartJul 15, 2020
Primary CompletionApr 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.5 years ago

Interventions

Indomethacindrug

One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.

Placebodrug

One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.

Endoscopy for Pancreatic Function Testingprocedure

All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.