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)

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study (12 months)

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.