Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT05771675

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

Led by Cedars-Sinai Medical Center · Updated on 2026-02-27

90

Participants Needed

5

Research Sites

135 weeks

Total Duration

On this page

Sponsors

C

Cedars-Sinai Medical Center

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form
  • Willingness to comply with all study procedures and be available for the study duration
  • Male or female, aged 18 to 75 years at enrollment
  • Diagnosis of Recurrent Acute or Chronic Pancreatitis not due to gallstones, medications, trauma, or autoimmune pancreatitis
  • Ability to take oral medication and willingness to follow dosing schedule
  • For females of childbearing potential: use of highly effective contraception for at least 1 month before and during the study, and for 1 month after study medication
  • For males of reproductive potential: use of condoms or effective contraception for at least 1 month before and during the study, and for 1 month after study medication
  • No prior pancreatic surgery
  • No use of statin medications in the past 6 months
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • History of autoimmune, medication-induced, or traumatic pancreatitis
  • Presence of primary pancreatic tumors such as pancreatic ductal adenocarcinoma or neuroendocrine tumors
  • Pancreatic metastasis from other cancers
  • History of solid organ transplant or HIV/AIDS
  • Known isolated pancreatic exocrine insufficiency without other eligible conditions
  • Use of specific interacting medications like itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil
  • Current use of simvastatin within the past 6 months
  • Medical or psychiatric conditions or substance abuse that would interfere with study participation
  • Active liver disease
  • Known pregnancy or positive pregnancy test within 2 days prior to research procedures
  • Currently incarcerated
  • Inability to comply with study activities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

University of Southern California

Los Angeles, California, United States, 90033

Actively Recruiting

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

3

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

4

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

5

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

A

Arax Shanlian

CONTACT

A

Arax Shanlian

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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