Acute Pancreatitis Clinical Trials

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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• Ability to take oral medication and be willing to adhere to the dosing regimen.

• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication.

• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication.

• No prior pancreatic surgery

• No current statin use for 6 months.

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
University of Southern California
RECRUITING
Los Angeles
Stanford University
RECRUITING
Stanford
Ohio
Ohio State University
RECRUITING
Columbus
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Contact Information
Primary
Arax Shanlian
arax.shanlian@cshs.org
3109671110
Backup
Arax Shanlian
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2027-06
Participants
Target number of participants: 90
Treatments
Experimental: Simvastatin
Participants receive Simvastatin 40mg capsule once daily for 6 months.
Placebo_comparator: Placebo
Participants receive Placebo capsule matching Simvastatin once daily for 6 months.
Sponsors
Collaborators: United States Department of Defense
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov