Clinical trial • Phase IV • Gastroenterology
SIMVASTATIN for Recurrent pancreatitis | Acute pancreatitis
Phase IV trial of SIMVASTATIN for Recurrent pancreatitis | Acute pancreatitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Recurrent pancreatitis | Acute pancreatitis
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 18-09-2024
- First CTIS Authorization Date
- 25-09-2024
Trial design
Randomised, active: simvastatin (film-coated tablet), max daily dose 40 mg (oral). comparator/placebo: lactose monohydrate (film-coated tablet), max daily dose 60 mg (oral). schedule not specified in provided data.-controlled Phase IV trial across 30 sites in Spain.
- Randomised
- Yes
- Comparator
- Active: SIMVASTATIN (film-coated tablet), max daily dose 40 mg (oral). Comparator/placebo: LACTOSE MONOHYDRATE (film-coated tablet), max daily dose 60 mg (oral). Schedule not specified in provided data.
- Target Sample Size
- 144
Eligibility
Recruits 144 Vulnerable population not selected; trial enrols adults (>=18). Written informed consent is required. Subject information sheet and informed consent form documents are provided for adults..
- Vulnerable Population
- Vulnerable population not selected; trial enrols adults (>=18). Written informed consent is required. Subject information sheet and informed consent form documents are provided for adults.
Inclusion criteria
- {"criterion_text":"- Adult (>=18) patients"}
- {"criterion_text":"- At least 2 episodes of AP or episodes of chronic pancreatitis"}
- {"criterion_text":"- Written consent to participate in the study"}
Exclusion criteria
- {"criterion_text":"- <2 episodes of Pancreatitis in the last 12 months."}
- {"criterion_text":"- Abstinence syndrome due to alcohol or drugs and/or delirium tremens in the last 6 months before recruitment"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Statin consumption in the previous year."}
- {"criterion_text":"- Contraindications to the use of Statins."}
- {"criterion_text":"- Cholelithiasis or choledocholitiasis diagnosed in the last episode of Pancreatitis."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Serum triglycerides >500 mg/dL without previous specific treatment before the last episode of Pancreatitis, or in patients expected to have a change in their specific hypertriglyceridemia treatment in less than 1 year"}
- {"criterion_text":"- Primary hyperparathyroidism that has been operated between last episode of Pancreatitis and recruitment or will be operated in less than 1 year"}
- {"criterion_text":"- Autoimmune pancreatitis"}
- {"criterion_text":"- Iatrogenic Pancreatitis"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Recurrence of Pancreatitis (dichotomous)","definition_or_measurement_approach":"Dichotomous variable: recurrence of pancreatitis; main aim to compare the incidence of new episodes of acute pancreatitis in patients consuming simvastatin vs placebo."}
Secondary endpoints
- {"endpoint_text":"- Recurrences (dichotomous variable), recurrence (Kaplan-Meier analysis), new-onset diabetes, new-onset exocrine pancreatic insufficiency, severity of recurrent Pancreatitis, 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.","definition_or_measurement_approach":"Includes dichotomous recurrence measures, time-to-event analysis by Kaplan-Meier for recurrence, assessment of new-onset diabetes and exocrine pancreatic insufficiency, severity grading of recurrent pancreatitis, counting days of hospitalization, counting ER visits and admissions for abdominal pain, and imaging assessment for signs of chronic pancreatitis."}
Recruitment
- Planned Sample Size
- 144
- Recruitment Window Months
- 91
- Consent Approach
- Written informed consent required from participants; adults (>=18) provide consent. Subject information sheet (SIS adults) and informed consent form (ICF adults) documents are available. No paediatric assent (paediatric population not selected). Language of documents not explicitly specified in the provided data (study title translations to Spanish are present).
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 144
Spain
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 25-09-2024
- Processing Time Days
- 5
- Number Of Sites
- 30
- Number Of Participants
- 144
Sites
- Site Name
- Sant Joan De Deu Barcelona Hospital
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Francesc Vida Mombiela
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Francesc Vida Mombiela
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- University Hospital Son Espases
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Maria del Carmen Garrido Durán
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Maria del Carmen Garrido Durán
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Lourdes Ruíz Rebollo
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Lourdes Ruíz Rebollo
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario De Burgos
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Manuel Alfonso Jiménez Moreno
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Manuel Alfonso Jiménez Moreno
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitari De Santa Maria
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Juan Armando Rodríguez Oballe
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Juan Armando Rodríguez Oballe
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Claudia Sánchez Marín
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Claudia Sánchez Marín
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital General Universitario San Jorge
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Blanca Belloc Barbastro
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Blanca Belloc Barbastro
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Adolfo Del Val Antoñana
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Manuel Alfonso Jiménez Moreno
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Leticia Betancor Hernández
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Leticia Betancor Hernández
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- J.Enrique Domínguez Múñoz
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- J.Enrique Domínguez Múñoz
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Alba Lira Aguilar
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Alba Lira Aguilar
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Eduardo Bajador Andreu
- Principal Investigator Email
- informacion.sector2@salud.aragon.es
- Contact Person Name
- Eduardo Bajador Andreu
- Contact Person Email
- informacion.sector2@salud.aragon.es
- Site Name
- Hospital Costa Del Sol
- Department Name
- Irigoin
- Principal Investigator Name
- Robin Rivera
- Principal Investigator Email
- robinri1416@gmail.com
- Contact Person Name
- Robin Rivera
- Contact Person Email
- robinri1416@gmail.com
- Site Name
- Hospital Universitario De Navarra
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Carlos Marra-Lopez Valenciano
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Carlos Marra-Lopez Valenciano
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Mar Concepción Martín
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Mar Concepción Martín
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Emma Martínez Moneo
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Emma Martínez Moneo
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital General Universitario De Valencia
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Isabel Conde Amiel
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Isabel Conde Amiel
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario Los Arcos Del Mar Menor
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Cristina Martínez Pascual
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Cristina Martínez Pascual
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario Lucus Augusti
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Eva Marià Marqués
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Eva Marià Marqués
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Andrés Del Pozo García
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Andrés Del Pozo García
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario Del Sureste - Empresa Publica Hosptial Del Sureste
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Jorge Antonio Nuñez Otero
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Jorge Antonio Nuñez Otero
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Antonio López Serrano
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Antonio López Serrano
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Quironsalud Malaga
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Pedro José Rosón Rodríguez
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Pedro José Rosón Rodríguez
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Isabel Pascual Moreno
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Isabel Pascual Moreno
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Judith Millastre Bocos
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Judith Millastre Bocos
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Rosa Martín Mateos
- Principal Investigator Email
- rosamartinmat@hotmail.com
- Contact Person Name
- Rosa Martín Mateos
- Contact Person Email
- rosamartinmat@hotmail.com
- Site Name
- Hospital Universitario Puerta Del Mar
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Jesús Leal Tellez
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Jesús Leal Tellez
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Maria Eugenia Lauret Brañas
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Maria Eugenia Lauret Brañas
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Complejo Hospitalario Universitario De Ourense
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Maria Francisco González
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Maria Francisco González
- Contact Person Email
- vailloalicia@gmail.com
- Site Name
- Hospital Universitario Fundacion Alcorcon
- Department Name
- Servicio de digestivo
- Principal Investigator Name
- Cristina Verdejo Gil
- Principal Investigator Email
- vailloalicia@gmail.com
- Contact Person Name
- Cristina Verdejo Gil
- Contact Person Email
- vailloalicia@gmail.com
Sponsor
Primary sponsor
- Full Name
- Hospital General Universitario Dr. Balmis
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- SIMVASTATIN
- Active Substance
- SIMVASTATIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 40 mg
- Investigational Product Name
- LACTOSE MONOHYDRATE
- Active Substance
- LACTOSE MONOHYDRATE
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 60 mg
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