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

Launched by CEDARS-SINAI MEDICAL CENTER · Mar 14, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the use of a medication called simvastatin to see if it can help improve the quality of life for adults suffering from Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP). The study aims to determine if simvastatin is a feasible and acceptable treatment option for these conditions, which can cause ongoing pain and digestive issues. The trial is currently not yet recruiting participants, but it is targeting adults aged 18 to 75 who have been diagnosed with these pancreatic conditions, as long as their symptoms are not caused by gallstones or certain other medical issues.

To be eligible for this study, participants need to agree to follow the study procedures and take oral medication as directed. They should not have had any pancreatic surgeries in the past and should not have been using simvastatin or other similar medications for the six months before the study starts. Women who can become pregnant must use effective contraception during the trial. Participants will be monitored throughout the study, providing important feedback on their experiences and any changes in their health. This trial is a first step in understanding whether simvastatin could be a useful treatment for people dealing with these challenging pancreatic conditions.

Gender

ALL

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 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.