SIMBA trial: Simvastatin in the Prevention of New Episodes of Acute Pancreatitis

Phase 1

• Conditions: Recurrent acute pancreatitis (RAP); MedDRA version: 20.0Level: PTClassification code 10033647Term: Pancreatitis acuteSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.0Level: PTClassification code 10033657Term: Pancreatitis relapsingSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-002445-31-ES
• Lead Sponsor: Enrique de Madaria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-05
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1.Adult (>=18) patients
2.At least 2 episodes of AP
3.Written consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72

Exclusion Criteria

1.Diagnosis of chronic pancreatitis
2.Last episode of AP >45 days from randomization; <2 episodes of AP in the last 12 months.
3.Statin consumption in the previous year.
4.Contraindications to the use of Statins
5.Cholelithiasis or choledocholitiasis diagnosed in the last episode of AP
6.Endoscopic sphyncterotomy and/or cholecystectomy and/or pancreatic surgery between last episode of AP and recruitment or patients who are expected to undergo one of this techniques in less than a year.
7.Serum triglycerides >500 mg/dL without previous specific treatment before the last episode of AP, or in patients expected to have a change in their specific hypertriglyceridemia treatment in less than 1 year
8.Primary hyperparathyroidism that has been operated between last episode of AP and recruitment or will be operated in less than 1 year
9.Autoimmune pancreatitis
10.Iatrogenic AP
11.Abstinence syndrome due to alcohol or drugs and/or delirium tremens in the last 6 months before recruitment
12.Previous (last year) failure to attend follow-up medical visits, social problems that may be associated to failure to take the medication or to perform an adequate follow-up

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Hypothesis: The consumption of simvastatin is associated to a lower incidence of new episodes of RAP<br>Main aim: to compare the incidence of new episodes of AP in patients with RAP consuming simvastatin vs placebo.;Secondary Objective: To compare the prevalence on imaging of signs of chronic pancreatitis (calcifications and/or dilated ductal system), as well as endocrine and exocrine pancreatic function at the end of follow-up. To provide data for a more ambitious project in case of a non-significant trend towards effectiveness of simvastatin.;Primary end point(s): Recurrence of AP (dichotomous);Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Recurrences (dichotomous variable), recurrence (Kaplan-Meier analysis), new-onset diabetes, new-onset exocrine pancreatic insufficiency, severity of recurrent AP, number of days admitted due to recurrent AP. Number of visits to the emergency room and admissions due to abdominal pain without meeting criteria for acute pancreatitis. Imaging signs of Chronic Pancreatitis.;Timepoint(s) of evaluation of this end point: 1 year