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

Overview

Información sobre este estudio

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).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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 Participants who are hospitalized for an episode of acute pancreatitis during study participation will be withdrawn from the study, and considered non-accrued.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

 

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Santhi Swaroop Vege, M.D.

Cerrado para la inscripción

Contact information:

Vincent Anani M.P.H.

(507)284-5660

Anani.Vincent@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20470484

Mayo Clinic Footer