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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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19 February 2015 |
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Main ID: |
NCT00156403 |
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Date of registration:
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08/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Pilot Study of Use of Calcium Channel Blocker to Decrease Inflammation and Pain in Hereditary Pancreatitis
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Scientific title:
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Hereditary Pancreatitis Amlodipine Trial(H-PAT): A Pilot Study |
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Date of first enrolment:
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August 2005 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00156403 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/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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David C Whitcomb, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chief, Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh and University of Pittsburgh Medical Center, M2, C-Wing, Presbyterian Hospital, 200 Lothrop Street, Pittsburgh PA 15213 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- mutation in cationic trypsinogen (PRSS1)gene
- age 6 years and above
- able to comply with study terms: taking daily oral medication, taking daily blood
pressure, filling in daily symptoms diary, coming to all follow-up visits
- having some symptoms of pain from pancreas
Exclusion Criteria:
- combination of mutations in the 2 other loci associated with pancreatitis: Cystic
fibrosis transmembrane regulator and serine protease inhibitor Kazal type 1 (having
mutations in both genes)
- pancreatic insufficiency (exocrine and endocrine)
- already being on an antihypertensive medication
- contraindication to taking amlodipine (allergic reaction, severe renal failure
(creatinine > 3 mg/dL; hepatic dysfunction signified by INR > 1.5)
- pregnancy or breastfeeding
- systemic disease that the investigators feel would place patient at undue risk of
being placed on amlodipine
- newly-started (within past 3 months) pancreatic enzymes, acid blocking medication,
antioxidants, or oral contraceptive medication
Age minimum:
6 Years
Age maximum:
N/A
Gender:
Both
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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: amlodipine (drug)
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Primary Outcome(s)
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efficacy: symptoms diary, SF-36, cytokines analysis
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safety of amlodipine: side effects, biochemistry, BP
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Secondary Outcome(s)
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feasibility: ease of obtaining patient symptoms information, whether subjects need to be followed up as frequently as designated in this pilot, whether doing regular laboratory tests changed management in any way (i.e. whether it was necessary)
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Secondary ID(s)
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CReFF Award, GCRC U Pittsburgh
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National Pancreas Foundation
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0505070
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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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