A Pilot Study of Use of Calcium Channel Blocker to Decrease Inflammation and Pain in Hereditary Pancreatitis
Completed · Phase 1/Phase 2
Conditions studied: Pancreatitis
In brief
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.
Key facts
- Study ID
- NCT00156403
- Run by
- University of Pittsburgh
- People needed
- 8
- Starts
- 2005-08-01
- Expected to finish
- 2005-12-01
- Last updated by the study team
- 2007-12-17
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- General Clinical Research Center, University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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