Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
WithdrawnPhase 2NCT02706236
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The study purpose is to characterize the effect of pancreatic enzyme supplementation on chronic pancreatitis type pain.
Study details
- Official title
- A Single-Center Prospective Randomized Placebo Controlled Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
- Conditions
- Pancreatitis
- Interventions
- Drug: Pancrelipase
- Drug: placebo
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Start date
- 2016-04
- Primary completion
- 2018-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Diagnosis of chronic pancreatitis based on chronic pancreatitis-type pain \> 6 months leading to impaired quality of life AND at least 1 of the following (27): * Confirmed diagnosis of hereditary pancreatitis (PRSS1 gene mutation) * History of recurrent acute pancreatitis (\>1 documented episode of characteristic abdominal pain associated with diagnostic imaging and/or elevated serum amylase or lipase \> 3 times upper limit of normal). * Pancreatic calcifications on CT scan * At least 2 of the following: * Endoscopic Ultrasound (EUS) with = or \> 4 criteria for chronic pancreatitis (hyperechoic foci, strands, or ducts, lobulation, irregular duct margin, visible side - branches, calcifications, cysts, ductal dilatation) (28) * Ductal (changes in side branch morphology) or parenchymal (loss of T1 signal intensity) abnormalities on secretin enhanced Magnetic resonance cholangiopancreatography (MRCP) * Abnormal endoscopic pancreatic secretory function tests (HCO3 \<= 75mmol/L at 30 or 45 minutes or \<= 80mmol/L at 1 hour * Subjects are capable of informed consent Exclusion Criteria: * Pregnancy * Lactation * Active acute pancreatitis or an episode of acute pancreatitis within 2 months of presentation for evaluation * Pancreatic cancer
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02706236