Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT00156403
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT00156403
Study Brief:
Protocol Section:
NCT00156403