Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05771675
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-03
First Post:
2023-02-02
Brief Title:
Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMV in CP
Brief Summary:
The purpose of this pilot study to examine the feasibility and acceptability of simvastatin in adults with Recurrent Acute Pancreatitis RAP and Chronic Pancreatitis CP
Detailed Description:
There are no available treatments for chronic pancreatitis CP or recurrent acute pancreatitis RAP and patients suffer with unremitting abdominal pain as the disease progress This pilot study will test the feasibility of conducting a clinical trial of simvastatin to enhance the quality of life and delay disease progression in chronic pancreatitis patients Emerging understanding of pancreas acinar cell organellar disorders underlying pancreatitis and the potential benefits of simvastatin to restore acinar cell homeostasis along with understanding of the pathways of the fibro-inflammatory response emanating from the disorders in the acinar cell allow the study team to propose a pilot placebo controlled double blind trial in patients with CP and RAP to test the effect of simvastatin on patient reported outcomes Of note RAP is a form of pancreatitis preceding CP
The Study Team hypothesizes that treatment with simvastatin will have a significant benefit for reducing pain improving health-related quality of life HRQoL and pancreatitis-related outcomes in patients with CP and RAP Changes in blood biomarkers during treatments will provide biochemical evidence for the effectiveness of the treatments The proposed study is a pilot double blind trial with 21 assignment of simvastatin vs placebo 90 patients with either CP or RAP will be enrolled over a 24-month recruitment period Treatment with simvastatin or placebo will be for 6 months Outcome measures will be obtained at baseline 3 months and 6 months and 6 months after discontinuation of treatment for a total of one year Feasibility and adherence will be monitored
The Primary aim of this pilot study is to examine feasibility and acceptability of the trial in adults with RAP and CP A priori thresholds to evaluate feasibility are 50 enrollment 15 attrition 75 adherence with doses 20 side effects and 75 acceptability ratings Multiple secondary outcome measures will be obtained that determine the effect of the treatments on pain and Quality of Life QoL The study plans to include male and female participants 18 years of age with Chronic and Recurrent Acute pancreatitis Each participant will be involved for a period of 12 months from enrollment to completion of the study unless withdrawn by the study team for reasons of safety or by the participant for personal reasons
The Study Team hypothesizes that treatment with simvastatin will have a significant benefit for reducing pain improving health-related quality of life HRQoL and pancreatitis-related outcomes in patients with CP and RAP Changes in blood biomarkers during treatments will provide biochemical evidence for the effectiveness of the treatments The proposed study is a pilot double blind trial with 21 assignment of simvastatin vs placebo 90 patients with either CP or RAP will be enrolled over a 24-month recruitment period Treatment with simvastatin or placebo will be for 6 months Outcome measures will be obtained at baseline 3 months and 6 months and 6 months after discontinuation of treatment for a total of one year Feasibility and adherence will be monitored
The Primary aim of this pilot study is to examine feasibility and acceptability of the trial in adults with RAP and CP A priori thresholds to evaluate feasibility are 50 enrollment 15 attrition 75 adherence with doses 20 side effects and 75 acceptability ratings Multiple secondary outcome measures will be obtained that determine the effect of the treatments on pain and Quality of Life QoL The study plans to include male and female participants 18 years of age with Chronic and Recurrent Acute pancreatitis Each participant will be involved for a period of 12 months from enrollment to completion of the study unless withdrawn by the study team for reasons of safety or by the participant for personal reasons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None