Status:
COMPLETED
A Pilot Study of Use of Calcium Channel Blocker to Decrease Inflammation and Pain in Hereditary Pancreatitis
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Pancreatitis
Eligibility:
All Genders
6+ years
Phase:
PHASE1
PHASE2
Brief Summary
This pilot study is a feasibility, safety, and preliminary benefits study to look at whether giving the calcium channel blocker amlodipine to people with hereditary pancreatitis as a prophylactic meas...
Detailed Description
Hereditary Pancreatitis is a rare, autosomal dominantly inherited condition causing mutations in the cationic trypsinogen gene. These mutations lead to excessive activation of trypsinogen within the p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00156403
Start Date
August 1 2005
End Date
December 1 2005
Last Update
December 17 2007
Active Locations (1)
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1
General Clinical Research Center, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213