Simvastatin in the Prevention of Recurrent Pancreatitis

NCT04021498 | Terminated Phase 3 DMC

• 1 other identifier: SIMBA-16
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Recurrent acute pancreatitis and recurrent relapses of inflammation in chronic pancreatitis are an important problem. In some cases, prevention of these acute flares of inflammation is not possible. Population-based studies and meta-analysis of randomized controlled trials suggest that statins may decrease the incidence of acute pancreatitis. SIMBA aims to investigate the effect of simvastatin on the incidence of new episodes of pancreatitis in recurrent acute pancreatitis and chronic pancreatitis. This is a non-profit, researcher-driven placebo-controlled multicenter (27 Spanish centers) randomized controlled trial

Conditions

Pancreatitis Relapsing

Keywords

Pancreatitis; Acute pancreatitis; Chronic pancreatitis; Simvastatin; Recurrent

Outcome Measures

Primary Outcomes (1)

• Primary end point

  Recurrence of pancreatitis during the follow-up period. Pancreatitis is defined as 2 or more of the following criteria: I) increased amylase and/or lipase in blood higher than 3 times the upper limit of normality, II) typical abdominal pain and III) signs of acute pancreatitis or acute flare of inflammation in chronic pancreatitis on imaging (CT scan or MRI).

  1 year

Secondary Outcomes (7)

• Secondary end point

  1 year

• New-onset exocrine pancreatic insufficiency

  1 year

• Chronic Pancreatitis on imaging

  1 year

• All-cause hospital admissions

  1 year

• Severity of pancreatitis

  1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo 1 year

Other: Placebo

Simvastatin

EXPERIMENTAL

40 mg 1 year

Drug: Simvastatin 40mg

Interventions

Simvastatin 40mg DRUG

phase III, triple-blind randomised placebo-controlled trial comparing simvastatin 40 mg/day versus placebo (lactose). One hundred and fifty eight patients with recurrent AP (at least 2 episodes) will be included (79 per arm of treatment). Treatment and follow-up will last for 12 months.

Also known as: Brand name: Simvastatin Normon, 40 mg

Simvastatin

Placebo OTHER

phase III, triple-blind randomised placebo-controlled trial comparing simvastatin 40 mg/day versus placebo (lactose). One hundred and fifty eight patients with recurrent AP (at least 2 episodes) will be included (79 per arm of treatment). Treatment and follow-up will last for 12 months.

Also known as: lactose (brand name: lactosa monohidrato Fagrón)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>=18) patients
• At least 2 episodes of acute pancreatitis or acute flares of chronic pancreatitis
• Written consent to participate in the study

You may not qualify if:

• \<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
• 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
• Pregnancy, breastfeeding

Sponsors & Collaborators

• Enrique de-Madaria: lead
• Instituto de Salud Carlos III: collaborator
• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: collaborator
• Generalitat Valenciana: collaborator

Study Sites (1)

Alicante

Alicante, Alicante, 03010, Spain

Location

Related Publications (2)

• Guilabert L, Cardenas-Jaen K, Vaillo-Rocamora A, Ruiz-Rebollo ML, Bolado-Concejo F, Martinez-Moneo E, Rivera-Irigoin R, Martin-Mateos R, Garcia-Rayado G, Lopez-Serrano A, Marti-Marques E, Rodriguez-Oballe JA, Francisco-Gonzalez M, Jimenez-Moreno MA, Canamares-Orbis P, Concepcion-Martin M, Pascual-Moreno I, Del Val A, Lauret-Brana E, Sanchez-Marin C, Del Pozo-Garcia AJ, Ledro-Cano D, Zapater P, Nunez-Otero J, Bernal-Lujan L, Singh VK, Papachristou GI, Garg PK, Wu BU, Mehta RM, de-Madaria E. Simvastatin in the prevention of recurrent pancreatitis: a triple-blinded randomised clinical trial (the SIMBA trial). Gut. 2026 Jan 2:gutjnl-2025-337154. doi: 10.1136/gutjnl-2025-337154. Online ahead of print.

  PMID: 41482454 DERIVED

• Cardenas-Jaen K, Vaillo-Rocamora A, Gracia A, Garg PK, Zapater P, Papachristou GI, Singh VK, Wu BU, de-Madaria E. Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial. Front Med (Lausanne). 2021 Feb 10;7:494. doi: 10.3389/fmed.2020.00494. eCollection 2020.

  PMID: 33644082 DERIVED

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis; Recurrence

Interventions

Simvastatin; Lactose

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Enrique de-Madaria, MD PhD

  Gastroenterology Department, Hospital General Universitario de Alicante, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: September 29, 2017
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)