Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156403
Status:
COMPLETED
Last Update Posted:
2007-12-17
First Post:
2005-09-08
Brief Title:
A Pilot Study of Use of Calcium Channel Blocker to Decrease Inflammation and Pain in Hereditary Pancreatitis
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Hereditary Pancreatitis Amlodipine TrialH-PAT A Pilot Study
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 pancreatic acinar cells and subsequent pancreatic inflammation Clinically this may be observed as recurrent acute pancreatitis chronic pancreatitis and eventual complications of exocrine and endocrine pancreatic insufficiencies and pancreatic adenocarcinoma Currently there are no specific treatment or prophylactic measures for this condition
Calcium is the physiologic switch to activate trypsinogen It has recently been found that the mutation sites affect how tightly calcium binds to trypsinogen with mutations leading to excessive calcium binding and subsequent excessive trypsinogen activation This study is to obtain baseline data on whether the prophylactic use of a long-acting calcium channel blocker amlodipine would lead to decrease in the inappropriate activation of trypsinogen and thereby decrease the subsequent pancreatic inflammation
Up to 15 subjects aged 6 years and above with mutations in the cationic trypsinogen gene PRSS1 will be recruited and undergo a 16-week trial This will include a one-month baseline symptoms assessment daily symptoms diary and blood pressure measurements with an automated home blood pressure monitor Subsequently subjects will be placed on between 25 - 10 mg amlodipine po qd with a weaning up and weaning down phase for approximately 10 weeks They will continue to fill out daily symptoms diary blood pressure measurements to ensure there are no decreases fill out periodic quality of life questionnaires and undergo periodic blood testing for routine biochemistry as well as more specialized testing for proteomics and other inflammatory cytokines analysis
The study has three main purposes to determine whether the use of amlodipine appears to be safe in this patient population to determine how frequently and how best to follow subjects while they are taking the medication and to determine whether there are any indications of potential benefits to the medication whether by decreased symptoms frequency severity or by inflammatory cytokines analysis
A subsequent larger study would be designed based on the above results
Calcium is the physiologic switch to activate trypsinogen It has recently been found that the mutation sites affect how tightly calcium binds to trypsinogen with mutations leading to excessive calcium binding and subsequent excessive trypsinogen activation This study is to obtain baseline data on whether the prophylactic use of a long-acting calcium channel blocker amlodipine would lead to decrease in the inappropriate activation of trypsinogen and thereby decrease the subsequent pancreatic inflammation
Up to 15 subjects aged 6 years and above with mutations in the cationic trypsinogen gene PRSS1 will be recruited and undergo a 16-week trial This will include a one-month baseline symptoms assessment daily symptoms diary and blood pressure measurements with an automated home blood pressure monitor Subsequently subjects will be placed on between 25 - 10 mg amlodipine po qd with a weaning up and weaning down phase for approximately 10 weeks They will continue to fill out daily symptoms diary blood pressure measurements to ensure there are no decreases fill out periodic quality of life questionnaires and undergo periodic blood testing for routine biochemistry as well as more specialized testing for proteomics and other inflammatory cytokines analysis
The study has three main purposes to determine whether the use of amlodipine appears to be safe in this patient population to determine how frequently and how best to follow subjects while they are taking the medication and to determine whether there are any indications of potential benefits to the medication whether by decreased symptoms frequency severity or by inflammatory cytokines analysis
A subsequent larger study would be designed based on the above results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| National Pancreas Foundation | None | None | None |
| CReFF Award GCRC U Pittsburgh | None | None | None |