Simvastatin Treatment to Improve Patient-Reported Outcomes in Chronic Pancreatitis

What is the Purpose of this Study?

The purpose of this pilot study is to evaluate a drug called simvastatin for potential treatment of adults with recurrent acute pancreatitis or chronic pancreatitis. Participants will receive simvastatin or placebo (inactive substance); they will be asked to complete questionnaires, and blood draws. Simvastatin is approved by the U.S. Food and Drug Administration (FDA) to help lower cholesterol, but its use in this study is experimental. Researchers hope that simvastatin will have positive effects in reducing chronic pain associated with chronic pancreatitis and recurrent acute pancreatitis, in addition to improving overall quality of life and outcomes.

Eligibility

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.

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.
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.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Simvastatin treatment to improve patient-reported outcomes in patients with chronic pancreatitis

Study Details

Disease Type/Condition

Other

Principal Investigator

Pandol, Stephen

Age Group

Adult

Phase

IRB Number

STUDY00002293

ClinicalTrials.gov ID

NCT05771675

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org