Chronic Pancreatitis Clinical Trial
Official title:
Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
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).
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 2:1 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. ;
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