Trial of Indomethacin in Chronic Pancreatitis

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

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 Overview

• Status: Completed
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Drug: Indomethacin; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Vincent Anani; Phone Number: 507-284-4660; Email: Anani.Vincent@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Any gender, age ≥ 18 years and < 60 years
2. Diagnosed with chronic pancreatitis per American Pancreatic Association guidelines (pancreatic calcifications and/or Cambridge 3-4 changes on CT, MRI, and/or ERCP)
3. Scheduled for an upper GI endoscopic procedure (EGD or EUS) for clinical or research) indications (not conflicting with current investigation).
4. Able to provide written informed consent.
5. Serum creatinine within normal laboratory range, as measured within 30 days of the baseline study endoscopy.
6. For females of reproductive potential: willing to use highly effective contraception while taking study medication and for an additional 5 days after completing study medication.

Exclusion Criteria:

1. Diagnosed with acute pancreatitis requiring hospitalization within the 6 weeks prior to study enrollment.
2. Habitual use of aspirin or non-steroidal anti-inflammatory medications (NSAIDs), defined as use more than once per week.
3. Any use of aspirin or NSAIDs within 1 week of baseline study endoscopy procedure.
4. Allergy to secretin, indomethacin or NSAIDs.
5. History of known chronic renal insufficiency or cirrhosis.
6. History of coronary artery disease, angina pectoris, myocardial infarction, cerebrovascular accident (stroke), or transient ischemic accident (TIA).
7. History of peptic ulcer or gastrointestinal bleeding.
8. Incarcerated.
9. Found to have active GI ulceration at the time of baseline endoscopy.
10. Hospitalized for acute pancreatitis while participating in this research protocol. Participants who are hospitalized for an episode of acute pancreatitis during study participation will be withdrawn from the study, and considered non-accrued.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral indomethacin 50 mg po BID; The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed NSAID. Commercially available indomethacin will be utilized in this study. One capsule orally BID for 28 days. Those in the indomethacin arm will receive indomethacin 50 mg BID. 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.	Drug: Indomethacin; 50 mg twice a day by mouth.
Placebo Comparator: Placebo po BID; Participants in both study arms will receive study medication, one capsule orally BID for 28 days. Those in the placebo arm will receive placebo capsules BID. 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.	Drug: Placebos; Lactose capsules not containing active study drug will be taken twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in prostaglandin E2 (PGE2) concentrations	Mean change in PGE2 concentrations	Baseline, 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pain	Measured using the self reported Brief Pain Inventory questionnaire	Baseline, 28 days
Changes in quality of life	Measured using the self reported PROMIS Global quesionnaire	Baseline, 28 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Santhi Vege, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): April 24, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Pancreatic Diseases; Chronic Disease; Pancreatitis; Pancreatitis, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Indomethacin
• Other Study ID Numbers: 18-008193; R21DK117212 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No