Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Pancreatitis
In brief
The study purpose is to characterize the effect of pancreatic enzyme supplementation on chronic pancreatitis type pain.
Key facts
- Study ID
- NCT02706236
- Run by
- Dartmouth-Hitchcock Medical Center
- People needed
- 0
- Starts
- 2016-04-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2018-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Pregnancy
- Lactation
- Active acute pancreatitis or an episode of acute pancreatitis within 2 months of presentation for evaluation
- Pancreatic cancer
Where it is running
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
Full record on ClinicalTrials.gov
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