Using simvastatin to improve outcomes in patients with chronic pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the feasibility and acceptability of simvastatin in adults suffering from Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP). The study will investigate whether simvastatin can enhance quality of life and delay disease progression by addressing underlying cellular disorders in the pancreas. It will be a double-blind, placebo-controlled trial involving 90 patients, with a treatment duration of 6 months and a recruitment period of 24 months. The study will also measure changes in blood biomarkers to assess the treatment's effectiveness.

Why it matters

Who can join: the full rules

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 to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication.
8. No prior pancreatic surgery
9. No current statin use for 6 months.

Exclusion Criteria:

1. Pregnancy or lactation
2. History of autoimmune, medication caused or traumatic pancreatitis.
3. Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1 cm. in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
4. Pancreatic metastasis from other malignancies.
5. History of solid organ transplant, HIV/AIDS.
6. Known isolated pancreatic exocrine insufficiency (i.e.., in the absence of any eligible inclusion criteria).
7. Subjects required to take itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil for other clinical indications.
8. Current simvastatin use within the past 6 months.
9. Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up.
10. Patients with active liver disease.
11. Known Pregnancy. All participants of childbearing potential, except if post-menopausal (i.e., no menses for ≥2 years) or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test.
12. Currently incarcerated.
13. Inability to comply with study activities.

Where it's running

• University of Southern California
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting
• University of Pittsburgh Medical Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Stephen Pandol, MD — Cedars-Sinai Medical Center
• Study coordinator: Arax Shanlian
• Email: arax.shanlian@cshs.org
• Phone: 3109671110

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.