NCT04207060

Trial of Indomethacin in Chronic Pancreatitis

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
DRUG	Indomethacin	One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
DRUG	Placebo	One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
PROCEDURE	Endoscopy for Pancreatic Function Testing	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.

Timeline

• Start date: 2020-07-15
• Primary completion: 2023-04-24
• Completion: 2023-04-24
• First posted: 2019-12-20
• Last updated: 2024-09-04
• Results posted: 2024-09-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study