Trial of Indomethacin in Chronic Pancreatitis

  • STATUS
    Recruiting
  • End date
    Mar 16, 2023
  • participants needed
    32
  • sponsor
    Mayo Clinic
Updated on 16 May 2022
endoscopic retrograde cholangiopancreatography

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.

Details
Condition Chronic Pancreatitis
Treatment placebos, indomethacin
Clinical Study IdentifierNCT04207060
SponsorMayo Clinic
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Any gender, age ≥ 18 years and < 60 years
Diagnosed with chronic pancreatitis per American Pancreatic Association guidelines (pancreatic calcifications and/or Cambridge 3-4 changes on CT, MRI, and/or ERCP)
Scheduled for an upper GI endoscopic procedure (EGD or EUS) for clinical or research) indications (not conflicting with current investigation)
Able to provide written informed consent
Serum creatinine within normal laboratory range, as measured within 30 days of the baseline study endoscopy
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

Diagnosed with acute pancreatitis requiring hospitalization within the 6 weeks prior to study enrollment
Habitual use of aspirin or non-steroidal anti-inflammatory medications (NSAIDs), defined as use more than once per week
Any use of aspirin or NSAIDs within 1 week of baseline study endoscopy procedure
Allergy to secretin, indomethacin or NSAIDs
History of known chronic renal insufficiency or cirrhosis
History of coronary artery disease, angina pectoris, myocardial infarction, cerebrovascular accident (stroke), or transient ischemic accident (TIA)
History of peptic ulcer or gastrointestinal bleeding
Incarcerated
Found to have active GI ulceration at the time of baseline endoscopy
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 Participants who are hospitalized for an episode of acute pancreatitis during study participation will be withdrawn from the study, and considered non-accrued
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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