Trial Outcomes & Findings for Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis (NCT NCT02743364)
NCT ID: NCT02743364
Last Updated: 2022-12-13
Results Overview
Change in peak bicarbonate level (mmol/l) from baseline up to 6 months. Decreased peak bicarbonate concentration indicates worsening pancreatic function.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Baseline to up to 6 months
Results posted on
2022-12-13
Participant Flow
Participant milestones
| Measure |
Arm I (Simvastatin)
Patients receive simvastatin PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Simvastatin: Given PO
|
Arm II (Placebo)
Patients receive placebo PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis
Baseline characteristics by cohort
| Measure |
Arm I (Simvastatin)
n=6 Participants
Patients receive simvastatin PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Simvastatin: Given PO
|
Arm II (Placebo)
n=2 Participants
Patients receive placebo PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 6 monthsChange in peak bicarbonate level (mmol/l) from baseline up to 6 months. Decreased peak bicarbonate concentration indicates worsening pancreatic function.
Outcome measures
| Measure |
Arm I (Simvastatin)
n=6 Participants
Patients receive simvastatin PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Simvastatin: Given PO
|
Arm II (Placebo)
n=2 Participants
Patients receive placebo PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Peak Bicarbonate Concentration, Measured Using Endoscopic Pancreatic Function Test (ePFT)
|
-8.20 mmol/l
Standard Deviation 22.7
|
5.50 mmol/l
Standard Deviation 0.707
|
SECONDARY outcome
Timeframe: Baseline to up to 6 monthsChange 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.
Outcome measures
| Measure |
Arm I (Simvastatin)
n=6 Participants
Patients receive simvastatin PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Simvastatin: Given PO
|
Arm II (Placebo)
n=2 Participants
Patients receive placebo PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in the Endoscopic Ultrasound Score (EUS)
|
0.500 score on a scale
Standard Deviation 1.38
|
0.500 score on a scale
Standard Deviation 0.707
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsExpression of three biomarkers, HGF (hepatocyte growth factor), Resistin, and FASL (Fas ligand) in fluorescent intensity (arbitrary units), as an estimate of immune analyte concentration.
Outcome measures
| Measure |
Arm I (Simvastatin)
n=6 Participants
Patients receive simvastatin PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Simvastatin: Given PO
|
Arm II (Placebo)
n=2 Participants
Patients receive placebo PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Serum and Pancreatic Secretions
Baseline HGF
|
5.72 median fluorescent intensity
Interval 5.2 to 6.22
|
7.13 median fluorescent intensity
Interval 6.25 to 8.01
|
|
Serum and Pancreatic Secretions
6 month HGF
|
5.76 median fluorescent intensity
Interval 5.29 to 6.23
|
5.99 median fluorescent intensity
Interval 5.18 to 6.8
|
|
Serum and Pancreatic Secretions
Baseline Resistin
|
13.79 median fluorescent intensity
Interval 12.99 to 14.6
|
12.39 median fluorescent intensity
Interval 11.93 to 12.86
|
|
Serum and Pancreatic Secretions
6 month Resistin
|
12.94 median fluorescent intensity
Interval 11.83 to 14.05
|
12.45 median fluorescent intensity
Interval 11.81 to 13.1
|
|
Serum and Pancreatic Secretions
Baseline FASL
|
4.99 median fluorescent intensity
Interval 4.67 to 5.3
|
4.83 median fluorescent intensity
Interval 4.65 to 5.02
|
|
Serum and Pancreatic Secretions
6 month FASL
|
4.83 median fluorescent intensity
Interval 4.48 to 5.18
|
4.82 median fluorescent intensity
Interval 4.62 to 5.02
|
SECONDARY outcome
Timeframe: Baseline to up to 6 monthsNumber of participants with pancreatitis-related hospital readmissions.
Outcome measures
| Measure |
Arm I (Simvastatin)
n=6 Participants
Patients receive simvastatin PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Simvastatin: Given PO
|
Arm II (Placebo)
n=2 Participants
Patients receive placebo PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Pancreatitis-related Readmissions
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to up to 6 monthsChange 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.
Outcome measures
| Measure |
Arm I (Simvastatin)
n=6 Participants
Patients receive simvastatin PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Simvastatin: Given PO
|
Arm II (Placebo)
n=2 Participants
Patients receive placebo PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Health-related Quality of Life.
Physical Functioning
|
5.6 score on a scale
Standard Deviation 6.6
|
6.7 score on a scale
Standard Deviation 9.4
|
|
Change in Health-related Quality of Life.
Role Functioning
|
30.6 score on a scale
Standard Deviation 35.6
|
25.0 score on a scale
Standard Deviation 35.4
|
|
Change in Health-related Quality of Life.
Cognitive Functioning
|
2.8 score on a scale
Standard Deviation 6.8
|
16.7 score on a scale
Standard Deviation 23.6
|
|
Change in Health-related Quality of Life.
Social Functioning
|
22.2 score on a scale
Standard Deviation 36.0
|
8.3 score on a scale
Standard Deviation 35.4
|
|
Change in Health-related Quality of Life.
Fatigue
|
-22.2 score on a scale
Standard Deviation 35.1
|
-50.0 score on a scale
Standard Deviation 39.3
|
|
Change in Health-related Quality of Life.
Pain
|
-8.3 score on a scale
Standard Deviation 36.1
|
-25.0 score on a scale
Standard Deviation 35.4
|
|
Change in Health-related Quality of Life.
Insomnia
|
-22.2 score on a scale
Standard Deviation 50.2
|
-33.3 score on a scale
Standard Deviation 47.1
|
|
Change in Health-related Quality of Life.
Overall
|
19.4 score on a scale
Standard Deviation 19.5
|
33.3 score on a scale
Standard Deviation 0
|
Adverse Events
Arm I (Simvastatin)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Simvastatin)
n=6 participants at risk
Patients receive simvastatin PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Simvastatin: Given PO
|
Arm II (Placebo)
n=2 participants at risk
Patients receive placebo PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
83.3%
5/6 • Number of events 12 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
50.0%
1/2 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
50.0%
1/2 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
1/6 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
0.00%
0/2 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
Other adverse events
| Measure |
Arm I (Simvastatin)
n=6 participants at risk
Patients receive simvastatin PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Simvastatin: Given PO
|
Arm II (Placebo)
n=2 participants at risk
Patients receive placebo PO QD for 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
83.3%
5/6 • Number of events 15 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
100.0%
2/2 • Number of events 3 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 2 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
50.0%
1/2 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
4/6 • Number of events 5 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
50.0%
1/2 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 5 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
50.0%
1/2 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 4 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
0.00%
0/2 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 3 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
0.00%
0/2 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
100.0%
2/2 • Number of events 2 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
50.0%
1/2 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
50.0%
1/2 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60