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Recruiting EARLY_Phase 1 NCT05771675

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

Trial Parameters

Condition Recurrent Acute Pancreatitis
Sponsor Cedars-Sinai Medical Center
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 90
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-10-24
Completion 2026-12
Interventions
SimvastatinPlacebo

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).

Eligibility Criteria

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18-75 at time of enrollment 4. Diagnosis of Recurrent Acute or Chronic Pancreatitis not attributable to gallstones (i.e., suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis. For CP, imaging studies that can be used for diagnosis classification using Cambridge criteria46,47. 5. Ability to take oral medication and be willing to adhere to the dosing regimen. 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication. 7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner for at least 1 month prior

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