A Study to Evaluate Indomethacin to Treat Chronic Pancreatitis (The PAIR Trial)

Overview

About this study

The purpose of this study is to assess the physiologic effect of orally administered indomethacin (IN) on pancreatic juice PGE2 concentrations in patients with chronic pancreatitis (CP).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Any gender.
  • Age ≥ 18 years and ≤ 70 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 Participants who are hospitalized for an episode of acute pancreatitis during study participation will be withdrawn from the study, and considered non-accrued.
  • Patients with indwelling pancreatic duct stents.
  • Patients status post Whipple procedures or Roux-en-Y gastric bypass due to inability to collect pancreatic fluid via the natural ampulla, unless having an EDGE procedure for clinical reasons.

Eligibility last updated 4/20/22. Questions regarding updates should be directed to the study team contact.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Santhi Swaroop Vege, M.D.

Closed for enrollment

Contact information:

Vincent Anani M.P.H.

(507)284-5660

Anani.Vincent@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20470484

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