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

NCT00156403 | Completed Phase 1

• 3 other identifiers: 0505070CReFF Award, GCRC U PittsburghNational Pancreas Foundation
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 measure can reduce the inflammatory process in the pancreas.

Conditions

Pancreatitis

Keywords

pancreatitis, hereditary; trypsinogen, cationic; pilot study

Outcome Measures

Primary Outcomes (2)

• safety of amlodipine: side effects, biochemistry, BP

• efficacy: symptoms diary, SF-36, cytokines analysis

Secondary Outcomes (1)

• 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)

Interventions

amlodipine (drug) DRUG

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

General Clinical Research Center, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pancreatitis; Hereditary pancreatitis

Interventions

Amlodipine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David C Whitcomb, MD, PhD

  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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: August 1, 2005
• Study Completion: December 1, 2005
• Last Updated: December 17, 2007

Record last verified: 2007-12

Locations

US (1)