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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Simvastatin
Drug40Mg Oral Tablet
Placebo
DrugMatching Simvastatin Placebo tablet
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: SimvastatinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Examine the feasibility and acceptability of testing the effect of simvastatin on health-related quality of life outcomes in patients with recurrent acute and chronic pancreatitis.
A priori thresholds to evaluate feasibility are: 50% enrollment, \<15% attrition, \>75% adherence with doses, \<20% side effects. A score of \>75% acceptability ratings per an "Acceptability Form" that will be provided during the last visit will be used to gauge the general acceptability of the intervention (Simvastatin or Placebo) and study procedures to each participating subject.
Time frame
End of study (12 Months)Secondary outcomes
1
Determine the effect of simvastatin treatment on health-related quality of life (QoL) outcomes in patients with recurrent acute and chronic pancreatitis.
Health-related quality of life measurements will be collected via questionnaires (PROMIS Sleep Disturbance and Physical Short Form, Physical Distress scale, pain scales, and the Pancreatic Quality of Life Instrument) to assess overall health, quality of life, and compare the mean change from baseline across the times points 3, 6, and 12 months between the treatment group and placebo in order to identify improvement in overall quality of life and pain management. The study will also collect blood samples to look for exploratory biomarkers to identify potential measures of response to treatment with the intent do develop larger efficacy focused trials.
Time frame
End of study (12 Months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cedars-Sinai Medical Center
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov