Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT04207060
Eligibility 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 Participants who are hospitalized for an episode of acute pancreatitis during study participation will be withdrawn from the study, and considered non-accrued.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04207060
Study Brief:
Protocol Section:
NCT04207060