Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCedars-Sinai Medical Center
About this trial
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).
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Stated 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 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.
Disqualifiers
Pregnancy or lactation
History of autoimmune, medication caused or traumatic pancreatitis.
Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (>1 cm. in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
Pancreatic metastasis from other malignancies.
Trial design
Treatments tested in this trial
- Simvastatin
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Cedars-Sinai Medical Center
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov