Trial of Indomethacin in Chronic Pancreatitis

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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 Participants who are hospitalized for an episode of acute pancreatitis during study participation will be withdrawn from the study, and considered non-accrued.