Actively Recruiting
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
26 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
Researchers are evaluating the use of simvastatin in adults with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP), conditions that currently have no available treatments and cause persistent abdominal pain. This pilot study aims to test the feasibility and acceptability of a clinical trial to see if simvastatin can improve quality of life and slow disease progression by restoring pancreatic cell health and reducing inflammation. RAP is considered a form of pancreatitis that precedes CP. Participants will be randomly assigned in a 2:1 ratio to receive either simvastatin 40mg capsules or matching placebo capsules once daily for 6 months. The study includes a 24-month recruitment period, and the treatment phase lasts 6 months. Outcomes will be measured at the start, 3 months, 6 months, and then 6 months after stopping treatment, totaling one year of participant involvement. During the study, participants will complete assessments related to pain and health-related quality of life, while adherence and side effects will be closely monitored. Blood biomarkers will also be measured to provide biochemical evidence of treatment effects. The primary goal is to assess feasibility with targets for enrollment, adherence, side effects, and acceptability. Participants will be followed for 12 months unless they withdraw or are withdrawn for safety reasons.
CONDITIONS
Brief Title
Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-75 at time of 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 regimen
- For females of reproductive potential: use of effective contraception before and during study, and for one month after
- For males of reproductive potential: use of effective contraception with partner before and during study, and for one month after
- No prior pancreatic surgery
- No current statin use within 6 months
You will not qualify if you...
- Pregnancy or lactation
- History of autoimmune, medication-caused, or traumatic pancreatitis
- Presence of primary pancreatic tumors or pancreatic metastasis
- History of solid organ transplant or HIV/AIDS
- Known isolated pancreatic exocrine insufficiency without other inclusion criteria
- Use of specific interacting medications like itraconazole, ketoconazole, erythromycin, and others
- Current simvastatin use within past 6 months
- Medical or psychiatric illnesses or substance abuse that would interfere with study participation
- Active liver disease
- Known pregnancy or failure to have negative pregnancy test if of childbearing potential
- Currently incarcerated
- Inability to comply with study activities
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take simvastatin or placebo capsules once daily for 6 months to evaluate effects on pain and quality of life.
Visits at baseline, 3 months, and 6 months during treatment
Duration - 6 months
Participants are monitored for 6 months after treatment ends to assess ongoing effects and safety.
1 visit at 6 months post-treatment
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
Research Team
A
Arax Shanlian
A
Arax Shanlian
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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