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Pancreatitis RelapsingPhase 3SIMBA-16NCT04021498

Simvastatin in the Prevention of Recurrent Pancreatitis

A Phase 3 study testing Simvastatin 40mg in people with Pancreatitis Relapsing, run by Enrique de-Madaria at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatitis Relapsing
What is being tested?
Simvastatin 40mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
1 siteSpain
Study dates
29 Sep 2017to 1 Mar 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • <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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Alicante

    Alicante, Alicante, 03010

Other trials in Spain

About this study

Official title: Simvastatin in the Prevention of Recurrent Pancreatitis, a Triple Blind, Randomized Controlled Trial

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

Read the detailed description

Acute pancreatitis (AP) is the 3rd cause of hospital admission due to gastrointestinal disease. Approximately 20% of the patients will relapse after a first episode of AP. The low frequency of relapse in biliary AP is due to the high effectiveness of cholecystectomy but a first episode of AP due to alcoholic or other etiologies is associated with relapse in one every four patients. Currently, besides counselling for alcohol and tobacco abstinence, there is no specific medical treatment that changes the natural history of recurrent AP. Recurrent AP is an intermediary stage in the pathogenesis of chronic pancreatitis (CP) and a subset of recurrent AP patients during their natural course transition to CP (one every three patients). Forty-five percent of patients with CP experience intermittent flares of pain. Simvastatin has been associated to a decrease in the incidence of AP in a population-based study (Wu et al, Gut. 2015) and in a meta-analysis of randomized controlled trials (Preiss et al, JAMA 2012).

The main aim of SIMBA (SIMvastatin in the prevention of recurrent pancreatitis, a triple Blind rAndomized controlled multicenter trial) is to compare the recurrence rate of pancreatitis in patients with established recurrent pancreatitis (acute pancreatitis and acute flares in chronic pancreatitis) consuming simvastatin versus placebo.

The secondary aims are 1) to compare in patients with recurrent AP at the end of follow-up period the progression to chronic pancreatitis on imaging (calcifications and/or dilated ductal system), as well as endocrine and exocrine pancreatic function; 2) to compare the severity of recurrent pancreatitis between both treatment arms.

Design: SIMBA is a triple-blind randomized placebo-controlled, parallel-group, superiority multicenter (27 Spanish centers) trial. This final protocol (version 4) was finished on June 20th 2018.

Being tested
Simvastatin 40mg, Placebo
Keywords
Pancreatitis, Acute pancreatitis, Chronic pancreatitis, Simvastatin, Recurrent
Medical subject headings
Pancreatitis, Chronic, Pancreatitis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simvastatin 40mgDrug

    Also called Brand name: Simvastatin Normon, 40 mg

    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.

  • PlaceboOther

    Also called lactose (brand name: lactosa monohidrato Fagrón)

    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.

Study groups in NCT04021498
Study groupRoleWhat they receive
PlaceboPlacebo comparatorplacebo 1 year
Receives: Other: Placebo
SimvastatinExperimental40 mg 1 year
Receives: Drug: Simvastatin 40mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 year

Secondary outcomes (7)

  1. Secondary end point

    New-onset diabetes at the end of follow-up, according to the American Diabetes Association criteria. Blood levels of glycosylated hemoglobin at the end of follow-up will also be compared to baseline (beginning of the study)

    Measured: 1 year

  2. New-onset exocrine pancreatic insufficiency

    New-onset exocrine pancreatic insufficiency defined by fecal elastase-1 <100 mcg/g. Fecal elastase-1 levels at the end of follow-up will also be compared to baseline

    Measured: 1 year

  3. Chronic Pancreatitis on imaging

    Chronic Pancreatitis on imaging at the end of follow-up, defined as calcifications and/or dilated pancreatic duct (≥4mm) on a CT scan

    Measured: 1 year

  4. All-cause hospital admissions

    Frequency of all-cause hospital admissions

    Measured: 1 year

  5. Severity of pancreatitis

    Severity of pancreatitis according to the revision of the Atlanta Classification (moderate-to-severe versus mild)

    Measured: 1 year

  6. Adherence to treatment

    Percentage of the planned treatment consumed by the patient

    Measured: 1 year

  7. Adverse events

    Frequency of adverse events

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study start29 Sep 2017
  3. Primary completion1 Mar 2025
  4. Study completion1 Mar 2025

Why it stopped: Slow recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04021498
Sponsor's protocol ID
SIMBA-16
Acronym
SIMBA-16
Status last verified
Mar 2025
First submitted
12 Jul 2019
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 May 12;75(6):1160-1168. doi: 10.1136/gutjnl-2025-337154.

    PubMed 41482454

  • 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.

    PubMed 33644082

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Simvastatin 40mg in people with Pancreatitis Relapsing, run by Enrique de-Madaria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary end point (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04021498, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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