Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2016 |
| End Date: | December 2018 |
| Contact: | Kartik Sampath, MD |
| Email: | Kartik.Sampath@hitchcock.org |
| Phone: | 603-650-5261 |
A Single-Center Prospective Randomized Placebo Controlled Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
The study purpose is to characterize the effect of pancreatic enzyme supplementation on
chronic pancreatitis type pain.
chronic pancreatitis type pain.
Study Type: Interventional, randomized, double-blind, placebo-controlled, crossover design,
efficacy study Intervention arm: Pancreatic enzyme replacement (Pancrelipase) with meals and
snacks daily, for 4 weeks.
Placebo arm: Lactose placebo tablets with meals and snacks, for 4 weeks. Washout Phase:
Weeks 4 to 6, there will be cessation of placebo or Pancrelipase use.
Crossover Phase: Weeks 6 to 10, initial placebo arm receives Pancrelipase, Pancrelipase arm
receives placebo
Surveys - Izbicki score and PANQOLI assessment occur at Week 0, 4, 6, and 10. Narcotic and
non-narcotic usage will also be noted at these intervals. Patient will also report the
tobacco and alcohol use.
efficacy study Intervention arm: Pancreatic enzyme replacement (Pancrelipase) with meals and
snacks daily, for 4 weeks.
Placebo arm: Lactose placebo tablets with meals and snacks, for 4 weeks. Washout Phase:
Weeks 4 to 6, there will be cessation of placebo or Pancrelipase use.
Crossover Phase: Weeks 6 to 10, initial placebo arm receives Pancrelipase, Pancrelipase arm
receives placebo
Surveys - Izbicki score and PANQOLI assessment occur at Week 0, 4, 6, and 10. Narcotic and
non-narcotic usage will also be noted at these intervals. Patient will also report the
tobacco and alcohol use.
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
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Principal Investigator: Timothy B Gardner, MD
Phone: 603-650-5261
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