Phase 2
N=8
Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis
Acute Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT02743364 ↗Enrolled (actual)
8
Serious AEs
75.0%
Results posted
Jan 2022
Primary outcome: Primary: Change in Peak Bicarbonate Concentration, Measured Using Endoscopic Pancreatic Function Test (ePFT) — -8.20; 5.50 mmol/l
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Placebo Administration (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Simvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak Bicarbonate Concentration, Measured Using Endoscopic Pancreatic Function Test (ePFT) |
-8.20; 5.50 | — |
| SECONDARY Change in the Endoscopic Ultrasound Score (EUS) |
0.500; 0.500 | — |
| SECONDARY Serum and Pancreatic Secretions |
5.72; 7.13; 5.76; 5.99; 13.79; 12.39 | — |
| SECONDARY Pancreatitis-related Readmissions |
5; 1 | — |
| SECONDARY Change in Health-related Quality of Life. |
5.6; 6.7; 30.6; 25.0; 2.8; 16.7 | — |
Summary
This randomized phase II trial studies how well simvastatin works in reducing pancreatitis (the inflammation of the pancreas) in patients with pancreatitis that occurs more than once (recurrent), has worsened quickly (acute), or has persisted or progressed over a long period of time (chronic). Simvastatin may decrease the inflammation of the pancreas by modulating the immune response responsible for inflammation. It is not yet known if simvastatin may be an effective treatment for pancreatitis.
Eligibility 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 = = 70%)
- Leukocytes >= 2,500/microliter
- Absolute neutrophil count >= 1,500/microliter
- Platelets >= 100,000/microliter
- Hemoglobin > 10 g/dL
- Total bilirubin = = 5 mm, or evidence of advanced chronic pancreatitis by computed tomography (CT) or magnetic resonance imaging (MRI) results in the past 12 months
Data sourced from ClinicalTrials.gov (NCT02743364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.