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Phase 2 N=27 Randomized Quadruple-blind Treatment

Trial of Indomethacin in Chronic Pancreatitis

Chronic Pancreatitis

Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change in Prostaglandin E2 (PGE2) Concentrations — -457.7; -840.4 pg/ml

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Indomethacin (Drug); Placebo (Drug); Endoscopy for Pancreatic Function Testing (Procedure)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
Apr 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Prostaglandin E2 (PGE2) Concentrations
-457.7; -840.4
SECONDARY
Changes in Pain Interference Score
-2.9; -0.4
SECONDARY
Change in Quality of Life (Mental Health)
-3.8; 0.1
SECONDARY
Change in Pain Composite Score
-1.3; -0.5
SECONDARY
Change in Quality of Life (Physical Health)
1.6; 1.4

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04207060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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