RecruitingEarly Phase 1NCT05771675

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


Sponsor

Cedars-Sinai Medical Center

Enrollment

90 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

Chronic pancreatitis — ongoing inflammation of the pancreas — causes persistent pain that can be debilitating and is poorly managed by current treatments. There is growing evidence that statins (cholesterol-lowering drugs commonly used for heart disease) may reduce inflammation in the pancreas due to their anti-inflammatory properties. This study tests whether simvastatin, a widely used statin, can reduce pain and improve quality of life in patients with recurrent acute or chronic pancreatitis. The study is open to adults aged 18–75 with a confirmed diagnosis of recurrent acute or chronic pancreatitis not caused by gallstones, medication, trauma, or autoimmune disease, who are not currently taking a statin. Participants must be able to swallow pills and use contraception if of reproductive potential. Exclusions include pregnancy, autoimmune or traumatic pancreatitis, pancreatic cancer or precancerous conditions, HIV/AIDS, organ transplant history, and needing certain drugs that interact with simvastatin. Participants take simvastatin or a placebo daily and are followed with pain questionnaires, quality of life scales, and blood tests. This research is important because chronic pancreatitis pain is notoriously treatment-resistant, and repurposing an inexpensive and well-understood drug like simvastatin could provide a meaningful new option for these patients.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSimvastatin

40Mg Oral Tablet

DRUGPlacebo

Matching Simvastatin Placebo tablet


Locations(5)

University of Southern California

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Stanford University

Stanford, California, United States

Ohio State University

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

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NCT05771675


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