A Pilot Study of Use of Calcium Channel Blocker to Decrease Inflammation and Pain in Hereditary Pancreatitis

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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 measure can reduce the inflammatory process in the pancreas.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Amlodipine; Calcium Channel Blockers

Criteria

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