Trial · NCT02743364

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

NCT02743364, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-01-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis. Trials, record NCT02743364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02743364

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis
NCT number: NCT02743364
Status: Completed
Phases: Phase 2
Enrollment: 8 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Acute Pancreatitis
Interventions: Laboratory Biomarker Analysis, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration, Simvastatin
First posted: 2016-04-19
Last updated: 2022-12-13
Results first posted: 2022-01-04

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Peak Bicarbonate Concentration, Measured Using Endoscopic Pancreatic Function Test (ePFT)	Baseline to up to 6 months	Change in peak bicarbonate level (mmol/l) from baseline up to 6 months. Decreased peak bicarbonate concentration indicates worsening pancreatic function.
Secondary	Change in the Endoscopic Ultrasound Score (EUS)	Baseline to up to 6 months	Change in EUS score (0-96) from baseline to up to 6 months. EUS Score is a measure of pancreatitis by the presence or absence of nine ductal and parenchymal criteria for CP: hyperechoic foci, hyperechoic strands, cysts, lobularity, calcifications, hyperechoic duct margins, visual side branches, main pancreatic duct dilation, and main pancreatic duct irregularity, which sum to a score ranging from 0 to 96. Presence of 6 or more standard criteria indicates advanced chronic pancreatitis. A positive score indicates an improvement. A negative score indicates a reduction.
Secondary	Serum and Pancreatic Secretions	Baseline and 6 months	Expression of three biomarkers, HGF (hepatocyte growth factor), Resistin, and FASL (Fas ligand) in fluorescent intensity (arbitrary units), as an estimate of immune analyte concentration.
Secondary	Pancreatitis-related Readmissions	Baseline to up to 6 months	Number of participants with pancreatitis-related hospital readmissions.
Secondary	Change in Health-related Quality of Life.	Baseline to up to 6 months	Change in health-related quality of life scores (1-100) from baseline to up to 6 months measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-PAN28(CP) scores. A positive value indicates improvement and a negative value indicates reduction.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Peak Bicarbonate Concentration, Measured Using Endoscopic Pancreatic Function Test (ePFT)	Baseline to up to 6 months	mmol/l	MEAN
SECONDARY	Change in the Endoscopic Ultrasound Score (EUS)	Baseline to up to 6 months	score on a scale	MEAN
SECONDARY	Serum and Pancreatic Secretions	Baseline and 6 months	median fluorescent intensity	LEAST_SQUARES_MEAN
SECONDARY	Pancreatitis-related Readmissions	Baseline to up to 6 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Health-related Quality of Life.	Baseline to up to 6 months	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Peak Bicarbonate Concentration, Measured Using Endoscopic Pancreatic Function Test (ePFT)	Arm I (Simvastatin)		-8.20	Standard Deviation 22.7	mmol/l
Change in Peak Bicarbonate Concentration, Measured Using Endoscopic Pancreatic Function Test (ePFT)	Arm II (Placebo)		5.50	Standard Deviation 0.707	mmol/l
Change in the Endoscopic Ultrasound Score (EUS)	Arm I (Simvastatin)		0.500	Standard Deviation 1.38	score on a scale
Change in the Endoscopic Ultrasound Score (EUS)	Arm II (Placebo)		0.500	Standard Deviation 0.707	score on a scale
Serum and Pancreatic Secretions	Arm I (Simvastatin)	Baseline HGF	5.72	95% Confidence Interval 5.20 to 6.22	median fluorescent intensity
Serum and Pancreatic Secretions	Arm II (Placebo)	Baseline HGF	7.13	95% Confidence Interval 6.25 to 8.01	median fluorescent intensity
Serum and Pancreatic Secretions	Arm I (Simvastatin)	6 month HGF	5.76	95% Confidence Interval 5.29 to 6.23	median fluorescent intensity
Serum and Pancreatic Secretions	Arm II (Placebo)	6 month HGF	5.99	95% Confidence Interval 5.18 to 6.80	median fluorescent intensity
Serum and Pancreatic Secretions	Arm I (Simvastatin)	Baseline Resistin	13.79	95% Confidence Interval 12.99 to 14.60	median fluorescent intensity
Serum and Pancreatic Secretions	Arm II (Placebo)	Baseline Resistin	12.39	95% Confidence Interval 11.93 to 12.86	median fluorescent intensity

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Simvastatin)	6
Overall Study	STARTED	Arm II (Placebo)	2
Overall Study	COMPLETED	Arm I (Simvastatin)	6
Overall Study	COMPLETED	Arm II (Placebo)	2
Overall Study	NOT COMPLETED	Arm I (Simvastatin)	0
Overall Study	NOT COMPLETED	Arm II (Placebo)	0

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal Pain	Gastrointestinal disorders	Arm I (Simvastatin)	5	6	15
other	Abdominal Pain	Gastrointestinal disorders	Arm II (Placebo)	2	2	3
other	Alanine aminotransferase increased	Investigations	Arm I (Simvastatin)	1	6	2
other	Alanine aminotransferase increased	Investigations	Arm II (Placebo)	1	2	1
other	Constipation	Gastrointestinal disorders	Arm I (Simvastatin)	4	6	5
other	Constipation	Gastrointestinal disorders	Arm II (Placebo)	1	2	1
other	Nausea	Gastrointestinal disorders	Arm I (Simvastatin)	3	6	5
other	Nausea	Gastrointestinal disorders	Arm II (Placebo)	1	2	1
other	Vomiting	Gastrointestinal disorders	Arm I (Simvastatin)	3	6	4
other	Vomiting	Gastrointestinal disorders	Arm II (Placebo)	0	2	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Simvastatin)	0	6
Total, all-cause mortality	Arm II (Placebo)	0	2
Total, other adverse events	Arm I (Simvastatin)	5	6
Total, other adverse events	Arm II (Placebo)	2	2
Total, serious adverse events	Arm I (Simvastatin)	5	6
Total, serious adverse events	Arm II (Placebo)	1	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA060553	The Robert H. Lurie Comprehensive Cancer Center	PLATANIAS, LEONIDAS C.	NORTHWESTERN UNIVERSITY	NATIONAL CANCER INSTITUTE	1993 to 2025

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I (Simvastatin) vs Arm II (Placebo): deaths from any cause	Trial comparisons
Arm I (Simvastatin) vs Arm II (Placebo): Pancreatitis-related Readmissions	Trial comparisons
Arm I (Simvastatin) vs Arm II (Placebo): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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API reference For AI assistants