RECRUITING

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

Conditions

Recurrent Acute Pancreatitis Chronic Pancreatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-10-24

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05771675

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18-75 at time of enrollment 4. 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. 5. Ability to take oral medication and be willing to adhere to the dosing regimen. 6. 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. 7. 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. 8. No prior pancreatic surgery 9. No current statin use for 6 months.	1. Pregnancy or lactation 2. History of autoimmune, medication caused or traumatic pancreatitis. 3. Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1 cm. in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors. 4. Pancreatic metastasis from other malignancies. 5. History of solid organ transplant, HIV/AIDS. 6. Known isolated pancreatic exocrine insufficiency (i.e.., in the absence of any eligible inclusion criteria). 7. Subjects required to take itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil for other clinical indications. 8. Current simvastatin use within the past 6 months. 9. Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up. 10. Patients with active liver disease. 11. Known Pregnancy. All participants of childbearing potential, except if post-menopausal (i.e., no menses for ≥2 years) or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test. 12. Currently incarcerated. 13. Inability to comply with study activities.

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18-75 at time of enrollment
4. 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.
5. Ability to take oral medication and be willing to adhere to the dosing regimen.
6. 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.
7. 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.
8. No prior pancreatic surgery
9. No current statin use for 6 months.

1. Pregnancy or lactation
2. History of autoimmune, medication caused or traumatic pancreatitis.
3. Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1 cm. in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
4. Pancreatic metastasis from other malignancies.
5. History of solid organ transplant, HIV/AIDS.
6. Known isolated pancreatic exocrine insufficiency (i.e.., in the absence of any eligible inclusion criteria).
7. Subjects required to take itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil for other clinical indications.
8. Current simvastatin use within the past 6 months.
9. Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up.
10. Patients with active liver disease.
11. Known Pregnancy. All participants of childbearing potential, except if post-menopausal (i.e., no menses for ≥2 years) or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test.
12. Currently incarcerated.
13. Inability to comply with study activities.

Contacts and Locations

Study Contact

Marissa Maiman

CONTACT

3109671109

marissa.maiman@cshs.org

Principal Investigator

Stephen Pandol, MD

PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Study Locations (Sites)

Marissa Maiman

Los Angeles, California, 90048

United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

Stephen Pandol, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-24

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-10-24

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Acute Pancreatitis
Chronic Pancreatitis