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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT05771675
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Simvastatin — DRUG
    40Mg Oral Tablet
  • Placebo — DRUG
    Matching Simvastatin Placebo tablet

Study Details

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).

Key Dates

Start date
Oct 24, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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. [ Time Frame: End of study (12 Months) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Arax Shanlian
[email protected]
3109671110
Erika Padilla
[email protected]
310-967-1109
Stephen Pandol, MD (PRINCIPAL_INVESTIGATOR)
University of Southern CaliforniaLos AngelesCalifornia90033
Jorge Zuniga-Gomez
[email protected]
323-442-0876
James Buxbaum, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityStanfordCalifornia94305
Lorena Pineda
[email protected]
6507252767
Walter Park, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Spencer Harris
[email protected]
614-366-7453
Usman Sajid
[email protected]
614-366-7453
Georgios Papachristou, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Kelly Wood
[email protected]
412-647-1458
Tina Tomko
[email protected]
412-647-1120
Dhiraj Yadav, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of Southern California· Los Angeles, CAStanford University· Stanford, CAOhio State University· Columbus, OHUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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