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HMG-CoA Reductase Inhibitor

Simvastatin for Chronic Pancreatitis (SMV in CP Trial)

Phase < 1
Waitlist Available
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study (12 months)
Awards & highlights

Summary

This trial tests if a drug can help adults with recurrent acute & chronic pancreatitis.

Who is the study for?
Adults aged 18-75 with Recurrent Acute Pancreatitis or Chronic Pancreatitis not caused by gallstones, medications, trauma, or autoimmune issues. Participants must be able to take oral meds and commit to the study's duration. Women of childbearing age and men must use effective contraception.
What is being tested?
The trial is testing simvastatin's effectiveness for improving patient-reported outcomes in those with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP). It compares simvastatin against a placebo to see if it can help manage pancreatitis symptoms.
What are the potential side effects?
Simvastatin may cause muscle pain, digestive problems, increased blood sugar levels, headache, difficulty sleeping, flushing of the skin, mild rash or dizziness. However, specific side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study (12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study (12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Secondary study objectives
Determine the effect of simvastatin treatment on health-related quality of life (QoL) outcomes in patients with recurrent acute and chronic pancreatitis.

Side effects data

From 2015 Phase 3 trial • 33 Patients • NCT02030041
11%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vitamin D and Placebo
Simvastatin and Placebo
Simvastatin and Vitamin D

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SimvastatinExperimental Treatment1 Intervention
Participants receive Simvastatin 40mg capsule once daily for 6 months.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive Placebo capsule matching Simvastatin once daily for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simvastatin
2012
Completed Phase 4
~1270

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
509 Previous Clinical Trials
165,823 Total Patients Enrolled
2 Trials studying Acute Pancreatitis
1,600 Patients Enrolled for Acute Pancreatitis
United States Department of DefenseFED
891 Previous Clinical Trials
332,388 Total Patients Enrolled
~60 spots leftby Dec 2025
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