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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02706236 |
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Date of registration:
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27/02/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
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Scientific title:
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A Single-Center Prospective Randomized Placebo Controlled Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02706236 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Timothy B Gardner, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dartmouth-Hitchcock Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pancreatitis
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Intervention(s)
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Drug: placebo
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Drug: Pancrelipase
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Primary Outcome(s)
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Change in pain scores based on Izbicki self-assessment score
[Time Frame: Measured at weeks 0,4,6 and 10]
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Secondary Outcome(s)
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Change in Narcotic Use
[Time Frame: 0, 4, 6 and 10 weeks of treatment]
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Quality of life
[Time Frame: Pancreatic Quality of Life Instrument (PANQOLI) assessment at weeks 0, 4, 6 and 10]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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