Trial of Indomethacin in Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207060
• Other study ID #: 18-008193
• Secondary ID: R21DK117212
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 15, 2020
• Est. completion date: April 24, 2023

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in prostaglandin E2 (PGE2) concentrations	Mean change in PGE2 concentrations	Baseline, 28 days
Secondary	Changes in pain	Measured using the self reported Brief Pain Inventory questionnaire	Baseline, 28 days
Secondary	Changes in quality of life	Measured using the self reported PROMIS Global quesionnaire	Baseline, 28 days