Recurrent acute pancreatitis (RAP) MedDRA version: 20.0 Level: PT Classification code 10033647 Term: Pancreatitis acute System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10033657 Term: Pancreatitis relapsing System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Simvastatina Normon 40 mg comprimidos recubiertos con película EFG
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: SIMVASTATIN
Current Sponsor code: 65199
Concentration u
Sponsors
Enrique de Madaria
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Diagnosis of chronic pancreatitis 2. Last episode of AP >45 days from randomization; 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Hypothesis: The consumption of simvastatin is associated to a lower incidence of new episodes of RAP 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactPancreatic Unit Coordinator
Servicio de Aparato Digestivo, Hospital General Universitario de Alicante
Outcome results
None listed