Status:
TERMINATED
Simvastatin in the Prevention of Recurrent Pancreatitis
Lead Sponsor:
Enrique de-Madaria
Collaborating Sponsors:
Instituto de Salud Carlos III
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Conditions:
Pancreatitis Relapsing
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. P...
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...
Eligibility Criteria
Inclusion
- Adult (\>=18) patients
- At least 2 episodes of acute pancreatitis or acute flares of chronic pancreatitis
- Written consent to participate in the study
Exclusion
- \<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
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT04021498
Start Date
September 29 2017
End Date
March 1 2025
Last Update
March 20 2025
Active Locations (1)
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1
Alicante
Alicante, Alicante, Spain, 03010