Pilot Study of Simvastatin to Improve Quality of Life and Pain in Adults with Recurrent Acute and Chronic Pancreatitis

What this Trial Is About

This research aims to evaluate the feasibility and acceptability of simvastatin treatment in adults with Recurrent Acute Pancreatitis RAP and Chronic Pancreatitis CP, conditions that currently have no available treatments and cause ongoing abdominal pain. The study is a pilot, double-blind, placebo-controlled trial designed to test if simvastatin can improve patient-reported outcomes including pain and health-related quality of life. It also seeks biochemical evidence of treatment effects through blood biomarker changes. Participants will be randomly assigned in a 21 ratio to receive either 40 mg of simvastatin or a matching placebo capsule once daily for six months. The study will enroll 90 patients over two years. Outcome measurements will be collected at baseline, 3 months, 6 months during treatment, and again at 12 months, six months after treatment ends. This design also monitors feasibility, adherence, side effects, and acceptability of the treatment. Participants will be involved for one year, undergoing assessments including health-related quality of life questionnaires and monitoring of blood biomarkers. Researchers will track adherence to medication, side effects, and collect data at multiple timepoints to evaluate the impact of simvastatin on pancreatitis-related outcomes. This includes follow-up six months after treatment to assess lasting effects and safety.

Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis