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HMG-CoA Reductase Inhibitor

Simvastatin for Chronic Pancreatitis (SMV in CP Trial)

Q: Does this medical trial accept participants who are of legal age?

This clinical trial seeks out those aged 18 and over, but not exceeding 75 years old.

Q: Am I eligible to participate in this research initiative?

Prospective participants in this medical study must have been diagnosed with acute pancreatitis and fall between 18 to 75 years of age. The trial is currently searching for 90 volunteers.

Q: Is there a possibility for new participants in this clinical trial?

Clinicaltrials.gov data indicates that, although this trial initially opened on January 1st 2024 and was last updated in November of 2023, it is no longer seeking participants. Alternately, there are 89 other studies currently enrolling patients.

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

SMV in CP Trial 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.Check my eligibility

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.See study design

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.

SMV in CP 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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%

Study treatment Arm

Vitamin D and Placebo

Simvastatin and Placebo

Simvastatin and Vitamin D

SMV in CP 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

501 Previous Clinical Trials

164,803 Total Patients Enrolled

1 Trials studying Acute Pancreatitis

800 Patients Enrolled for Acute Pancreatitis

United States Department of DefenseFED

865 Previous Clinical Trials

327,609 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial accept participants who are of legal age?

"This clinical trial seeks out those aged 18 and over, but not exceeding 75 years old."

Answered by AI

Am I eligible to participate in this research initiative?

"Prospective participants in this medical study must have been diagnosed with acute pancreatitis and fall between 18 to 75 years of age. The trial is currently searching for 90 volunteers."

Answered by AI

Is there a possibility for new participants in this clinical trial?

"Clinicaltrials.gov data indicates that, although this trial initially opened on January 1st 2024 and was last updated in November of 2023, it is no longer seeking participants. Alternately, there are 89 other studies currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis

Stephen Pandol, MD 2024. "Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05771675.

All > Chronic Pancreatitis