Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT02743364
• Date of registration: 15/04/2016
• Prospective Registration: Yes
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis
• Scientific title: Statin Therapy to Reduce the Risk of Recurrent Pancreatitis
• Date of first enrolment: September 19, 2016
• Target sample size: 8
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02743364
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Marc T Goodman
• Affiliation: Northwestern University

Key inclusion & exclusion criteria

Inclusion Criteria:

- At least two episodes of acute pancreatitis in the past 12 months; acute pancreatitis
is defined any 2 of the following: (1) typical upper abdominal pain; (2) elevation in
serum amylase or lipase >= 3 times upper limit of normal; (3) features of acute
pancreatitis on cross-sectional imaging

- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

- Leukocytes >= 2,500/microliter

- Absolute neutrophil count >= 1,500/microliter

- Platelets >= 100,000/microliter

- Hemoglobin > 10 g/dL

- Total bilirubin =< 3.0 x institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 1.5 x institutional ULN; patients whose AST/ALT levels normalize by screen 2 after
an abnormal test will be included in the trial

- Creatinine < 1.5 mg/dL

- Women of child-bearing potential must have a confirmed negative pregnancy test result
prior to enrollment

- The effects of simvastatin on the developing human fetus at the recommended
therapeutic dose are unknown; for this reason and because statins are known to be
teratogenic, women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
entry and for the duration of study participation; should a woman become pregnant or
suspect she is pregnant while participating in this study, she should inform her study
physician immediately; it is not known whether simvastatin is excreted into human
milk; however, a small amount of another drug in this class does pass into breast
milk; because statins have the potential for serious adverse reactions in nursing
infants, women who receive treatment with simvastatin should not breastfeed their
infants

- Ability to understand and the willingness to sign a written informed consent document
and medical release

- Willing and able to comply with trial protocol and follow-up

Exclusion Criteria:

- Prior or current use of statin medication, or current use of gemfibrozil,
cyclosporine, danazol, lomitapide, verapamil, diltiazem, dronedarone, amiodarone,
amlodipine, ranolazine, or strong cytochrome P450, family 3, subfamily A, polypeptide
4 (CYP3A4) inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole,
human immunodeficiency virus [HIV] protease inhibitors, boceprevir, telaprevir,
erythromycin, clarithromycin, telithromycin, nefazodone, or cobicistat-containing
products)

- History of chronic myopathy

- Current use of any other investigational agents

- History of adverse effects, intolerance, or allergic reactions attributed to compounds
of similar chemical or biologic composition to simvastatin (i.e., other statin
medications)

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Women who are pregnant or breastfeeding; pregnant women are excluded from this study
because simvastatin is a lipid-lowering agent with the potential for teratogenic or
abortifacient effects; because there is an unknown but potential risk for adverse
events in nursing infants secondary to treatment of the mother with simvastatin,
breastfeeding should be discontinued if the mother is treated with simvastatin

- Presence of gallstones and hypertriglyceridemia (level greater than 800 mg/dl) that
requires medical or surgical intervention; note: we will include patients who had an
independent episode of pancreatitis after a cholecystectomy, but exclude patients who
are candidates for cholecystectomy

- History of pancreatic adenocarcinoma (at any time)

- History of active malignancy in the past 2 years (excluding basal/squamous cell skin
cancer or prostate cancer with a Gleason score 6 or less)

- Known active infection with HIV

- Concurrent illness, such as known psychiatric disorders or substance abuse (i.e.,
average alcohol consumption of more than 5 drinks per day), which in the opinion of
the investigators would compromise either the patient or the integrity of the data

- Laboratory (lab) results do not meet inclusion criteria

- Recurrent pancreatitis episode is iatrogenic (endoscopic retrograde
cholangiopancreatography [ERCP] induced)

- Advanced chronic pancreatitis as determined by the following criteria: EUS score
greater than 6, calcifications in combination with atrophy and/or dilation of >= 5 mm,
or evidence of advanced chronic pancreatitis by computed tomography (CT) or magnetic
resonance imaging (MRI) results in the past 12 months



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Pancreatitis

Intervention(s)

Other: Questionnaire Administration

Other: Placebo Administration

Other: Laboratory Biomarker Analysis

Drug: Simvastatin

Other: Quality-of-Life Assessment

Primary Outcome(s)

Change in peak bicarbonate concentration, measured using endoscopic pancreatic function test (ePFT) [Time Frame: Baseline to up to 6 months]

Secondary Outcome(s)

Change in the endoscopic ultrasound score [Time Frame: Baseline to up to 6 months]

Change in pancreatitis-related readmissions [Time Frame: Baseline to up to 6 months]

Change in quality of life [Time Frame: Baseline to up to 6 months]

Change in serum and pancreatic secretions [Time Frame: Baseline to up to 6 months]

Secondary ID(s)

P30CA060553

N01-CN-2012-00035

N01CN00035

NCI2014-04-01

NWU2014-04-01

NCI-2016-00437

Source(s) of Monetary Support

Please refer to primary and secondary sponsors