Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
Cedars-Sinai Medical Center
Summary
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).
Description
There are no available treatments for chronic pancreatitis (CP) or recurrent acute pancreatitis (RAP) and patients suffer with unremitting abdominal pain as the disease progress. This pilot study will test the feasibility of conducting a clinical trial of simvastatin to enhance the quality of life and delay disease progression in chronic pancreatitis patients. Emerging understanding of pancreas acinar cell organellar disorders underlying pancreatitis and the potential benefits of simvastatin to restore acinar cell homeostasis along with understanding of the pathways of the fibro-inflammatory r…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- DrugSimvastatin
40Mg Oral Tablet
- DrugPlacebo
Matching Simvastatin Placebo tablet
Locations (5)
- University of Southern CaliforniaLos Angeles, California
- Cedars-Sinai Medical CenterLos Angeles, California
- Stanford UniversityStanford, California
- Ohio State UniversityColumbus, Ohio
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania