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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05771675
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