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    Summary
    EudraCT Number:2016-002445-31
    Sponsor's Protocol Code Number:SIMBA-16
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-08-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-002445-31
    A.3Full title of the trial
    SIMBA trial: Simvastatin in the Prevention of Recurrent Acute Pancreatitis, a Triple Blind Randomized Controlled Trial
    Ensayo SIMBA: Simvastatina en la prevención de pancreatitis aguda recurrente: ensayo clínico triple ciego controlado con placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SIMBA trial: Simvastatin in the Prevention of New Episodes of Acute Pancreatitis
    Ensayo SIMBA: Simvastatina en la prevención de nuevos episodios de pancreatitis aguda
    A.3.2Name or abbreviated title of the trial where available
    Simvastatin in the Prevention of Pancreatitis
    Simvastatina en la prevención de pancreatitis
    A.4.1Sponsor's protocol code numberSIMBA-16
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEnrique de Madaria
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAsociación Española de Gastroenterología (AEG, Spanish Association of Gastroenterology)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServicio de Aparato Digestivo, Hospital General Universitario de Alicante
    B.5.2Functional name of contact pointPancreatic Unit Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressPintor Baeza s/n, Servicio de Aparato Digestivo,4ª planta C, Hospital General Universitario Alicante
    B.5.3.2Town/ cityAlicante
    B.5.3.3Post code03010
    B.5.3.4CountrySpain
    B.5.4Telephone number0034965933468
    B.5.5Fax number0034965933468
    B.5.6E-mailmadaria@hotmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Simvastatina Normon 40 mg comprimidos recubiertos con película EFG
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Normon, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSIMVASTATIN
    D.3.9.2Current sponsor code65199
    D.3.9.4EV Substance CodeSUB10529MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent acute pancreatitis (RAP)
    Pancreatitis aguda recurrente (PAR)
    E.1.1.1Medical condition in easily understood language
    Recurrent (2 or more) acute pancreatitis
    Pancreatitis aguda recurrente (2 o más episodios)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033647
    E.1.2Term Pancreatitis acute
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033657
    E.1.2Term Pancreatitis relapsing
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    Hipótesis: el consumo de simvastatina se asocia a una menor incidencia de nuevos episodios de PAR.
    Objetivo principal: comparar la incidencia de nuevos episodios de pancreatitis aguda en pacientes con PAR que consumen simvastatina frente a placebo
    E.2.2Secondary objectives of the trial
    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.
    Comparar la prevalencia en pruebas de imagen de signos de pancreatitis crónica (calcificaciones y/o dilatación de sistema ductal), así como insuficiencia pancreática endocrina y exocrina al final del periodo de seguimiento. Aportar datos para un estudio de mayores dimensiones en caso de detectarse diferencias no estadísticamente significativas que sugieran efectividad de la simvastatina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult (>=18) patients
    2. At least 2 episodes of AP
    3. Written consent to participate in the study
    1. Pacientes adultos (>=18 años)
    2. Al menos 2 episodios de pancreatitis aguda
    3. Consentimiento informado para participar en el estudio
    E.4Principal 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
    1. Diagnóstico de pancreatitis crónica
    2. Tiempo entre último episodio de pancreatitis aguda y reclutamiento superior a 45 dias; menos de 2 episodios de pancreatitis aguda en los últimos 12 meses
    3. Consumo de estatinas en el año previo al reclutamiento.
    4. Contraindicaciones al uso de estatinas
    5. Colelitiasis o coledocolitiasis diagnosticadas en el último episodio de pancreatitis aguda
    6. Esfinterotomía endoscópica y/o colecistectomía y/o cirugía pancreática entre el último episodio de pancreatitis aguda y el reclutamiento, o que se prevea que se realicen en <1 año tras reclutamiento
    7. Triglicéridos séricos >500 mg/dL sin tratamiento específico previo antes del último episodio de pancreatitis aguda, o pacientes en los que se prevé un cambio en el tratamiento hipolipemiante en menos de un año
    8. Hiperparatiroidismo primario que haya sido operado entre la última pancreatitis aguda y el reclutamiento o que se prevea que se opere antes de un año.
    9. Pancreatitis autoinmune
    10. Pancreatitis iatrogénica
    11. Síndrome de abstinencia por alcohol o drogas y/o delirium tremens en los últimos 6 meses previos al reclutamiento
    12. Fallo del paciente en acudir a seguimientos médicos, problema social que se pueda asociar a ello o a no consumir el tratamiento o participar en el seguimiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Recurrence of AP (dichotomous)
    Recurrencia de pancreatitis aguda (variable dicotómica)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 año
    E.5.2Secondary 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.
    Recurrencias de pancreatitis aguda (variable dicotómica), recurrencia (análisis de Kaplan-Meier), diabetes de novo, insuficiencia pancreática exocrina de novo, gravedad de recurrencia de pancreatitis, número de días hospitalizado por pancreatitis recurrente. Número de visitas a urgencias e ingresos por dolor abdominal sin cumplir criterios de pancreatitis aguda. Signos por imagen de pancreatitis crónica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    1 año
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The trial will end:
    A: After the last visit of the last subject undergoing the trial
    B: If the Sponsor considers that recruitment is too slow
    C: If the Sponsors considers that there is a safety issue
    D: If an interim analysis suggests that simvastatin is not associated to a lower incidence of recurrent acute pancreatitis or it is associated to a very important prophylactic effect (significant differences in the interim analysis)
    El ensayo acabará:
    A: tras la última visita del último paciente incluído
    B: Si el promotor considera que el reclutamiento es demasiado lento
    C: Si el promotor considera que hay un problema de seguridad
    D: Si en un análisis intermedio no se observa beneficio en el consumo de simvastatina o este es muy importante
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state144
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
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