Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
144
Countries
1
Sites
30
Recurrent pancreatitis
Hypothesis: The consumption of simvastatin is associated to a lower incidence of new episodes of RP Main aim: to compare the incidence of new episodes of AP in patients with RP consuming simvastatin vs placebo.
Key facts
- Sponsor
- Hospital General Universitario Dr. Balmis
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- completed 1 Jan 2025
- Decision date (initial)
- 2024-09-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513188-17-03
- EudraCT number
- 2016-002445-31
- ClinicalTrials.gov
- NCT04021498
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Hypothesis: The consumption of simvastatin is associated to a lower incidence of new episodes of RP
Main aim: to compare the incidence of new episodes of AP in patients with RP consuming simvastatin vs placebo.
Secondary objectives 1
- 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.
Conditions and MedDRA coding
Recurrent pancreatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10033647 | Pancreatitis acute | 100000004856 |
| 21.1 | PT | 10033657 | Pancreatitis relapsing | 100000004856 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Simvastatin in the Prevention of Recurrent Pancreatitis, a Triple Blind, Randomized Controlled Trial a Triple Blind, Randomized Controlled Trial
|
Randomised Controlled | Double | [{"id":82713,"code":2,"name":"Investigator"},{"id":82714,"code":4,"name":"Analyst"},{"id":82717,"code":1,"name":"Subject"},{"id":82715,"code":5,"name":"Carer"},{"id":82716,"code":3,"name":"Monitor"}] |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513188-17-02 | Simvastatin in the Prevention of Recurrent Pancreatitis, a Triple Blind, Randomized Controlled Trial. | Hospital General Universitario Dr. Balmis |
| 2024-513188-17-00 | Simvastatin in the Prevention of Recurrent Pancreatitis, a Triple Blind, Randomized Controlled Trial. | Hospital General Universitario Dr. Balmis |
| 2024-513188-17-01 | Simvastatin in the Prevention of Recurrent Pancreatitis, a Triple Blind, Randomized Controlled Trial. | Hospital General Universitario Dr. Balmis |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Adult (>=18) patients
- At least 2 episodes of AP or episodes of chronic pancreatitis
- Written consent to participate in the study
Exclusion criteria 11
- <2 episodes of Pancreatitis in the last 12 months.
- Statin consumption in the previous year.
- Contraindications to the use of Statins.
- Cholelithiasis or choledocholitiasis diagnosed in the last episode of Pancreatitis.
- 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.
- 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
- Primary hyperparathyroidism that has been operated between last episode of Pancreatitis and recruitment or will be operated in less than 1 year
- Autoimmune pancreatitis
- Iatrogenic Pancreatitis
- Abstinence syndrome due to alcohol or drugs and/or delirium tremens in the last 6 months before recruitment
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Recurrence of Pancreatitis (dichotomous)
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB10529MIG · Substance
- Active substance
- Simvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12098MIG · Substance
- Active substance
- Lactose Monohydrate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital General Universitario Dr. Balmis
- Sponsor organisation
- Hospital General Universitario Dr. Balmis
- Address
- Avinguda Del Pintor Baeza 12
- City
- Alicante
- Postcode
- 03010
- Country
- Spain
Scientific contact point
- Organisation
- Hospital General Universitario Dr. Balmis
- Contact name
- Alicia Vaillo
Public contact point
- Organisation
- Hospital General Universitario Dr. Balmis
- Contact name
- Alicia Vaillo
Locations
1 EU/EEA country · 30 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 144 | 30 |
| Rest of world | — | 0 | — |
Investigational sites
Complejo Hospitalario Universitario Insular Materno Infantil
Servicio de digestivo, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Clinico Universitario De Valladolid
Servicio de digestivo, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Universitario De Navarra
Servicio de digestivo, Irunlarrea Kalea 3, 31008, Pamplona
Hospital General Universitario San Jorge
Servicio de digestivo, Avenida de Martínez de Velasco, 36, Huesca
Hospital Universitari De Santa Maria
Servicio de digestivo, Av Alcalde Rovira Roure 44, 25198, Lleida
Hospital General Universitario De Valencia
Servicio de digestivo, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Costa Del Sol
Irigoin, Terreno Autovia Mediterraneo A-7 S/n, 29603, Marbella
Hospital Universitario De Cruces
Servicio de digestivo, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Puerta Del Mar
Servicio de digestivo, Avenida De Ana De Viya 21, 11009, Cadiz
Hospital Clinico Universitario Lozano Blesa
Servicio de digestivo, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Unviersitario Miguel Servet
Servicio de digestivo, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Dr Peset Aleixandre
Servicio de digestivo, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Universitario De Burgos
Servicio de digestivo, Avenida De Las Islas Baleares 3, 09006, Burgos
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Servicio de digestivo, Avenida Menendez Y Pelayo 4, 46010, Valencia
Complexo Hospitalario Universitario De Santiago
Servicio de digestivo, Calle Choupana Da S/n, 15706, Santiago De Compostela
Sant Joan De Deu Barcelona Hospital
Servicio de digestivo, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Complejo Hospitalario Universitario De Ourense
Servicio de digestivo, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Universitario Y Politecnico La Fe
Servicio de digestivo, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Fundacion Alcorcon
Servicio de digestivo, Calle Budapest 1, 28922, Alcorcon
Hospital Universitario Ramon Y Cajal
Servicio de digestivo, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Hospital Son Espases
Servicio de digestivo, Carretera Valldemossa 79, 07120, Palma
Hospital Quironsalud Malaga
Servicio de digestivo, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitario Marques De Valdecilla
Servicio de digestivo, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario 12 De Octubre
Servicio de digestivo, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Central De Asturias
Servicio de digestivo, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Lucus Augusti
Servicio de digestivo, Rua Dr. Ulises Romero 1, 27003, Lugo
Parc Tauli Hospital Universitari
Servicio de digestivo, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Universitario Los Arcos Del Mar Menor
Servicio de digestivo, Paraje Torre Octavio 54, 30739, Pozo Aledo
Hospital Universitario Del Sureste - Empresa Publica Hosptial Del Sureste
Servicio de digestivo, Ronda Del Sur 10, 28500, Arganda Del Rey
Hospital De La Santa Creu I Sant Pau
Servicio de digestivo, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Simvastatin in the prevention of recurrent pancreatitis: a triple-blinded randomised clinical trial SUM-134395
|
2026-05-18T11:23:08 | Submitted | Summary of Results |
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo_SIMBA_16_V4 | 1 |
| Recruitment arrangements (for publication) | Recrutiment arrangemets | 1 |
| Subject information and informed consent form (for publication) | ICF adults | 1 |
| Subject information and informed consent form (for publication) | SIS adults | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ficha tecnica | 1 |
| Summary of results (for publication) | full | 1 |
| Synopsis of the protocol (for publication) | ResumenSIMBA-16 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-18 | Spain | Acceptable with conditions 2024-09-25
|
2024-09-25 |