A phase IV double-blind, randomized, placebo-controlled, multi-center study with pancreatic enzyme replacement therapy (PERT) in subjects suffering from pancreatic exocrine insufficiency (PEI) after acute necrotizing pancreatitis.

Fundación para la Investigación en Enfermedades del Aparato Digestivo0 个研究点开始时间: 2014年7月22日最近更新: 2014年8月28日

试验速览

暂无简介。

•1.Patients between 18 and 80 years old, 2 weeks after discharge from the hospital after an attack of acute necrotizing pancreatitis as defined by a CT scan Balthazar score of ?6.
•2.Written informed consent.
•3.PEI diagnosed at inclusion by the 13C-MTG breath test and defined as a 13C-CCR <29%.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 18

•1.Age < 18 years or > 80 years.
•2.Pregnancy or lactancy.
•3.Unwillingness or inability to understand the study and sign the consent, or to accomplish with the visits and procedures of the study.
•4.Diagnosis of chronic pancreatitis or pancreatic cancer.
•5.Any kind of uncured malignant disease.
•6.Need of any therapy known to influence pancreatic secretion (e.g. somatostatin and somatostatin analogs).
•7.Need for any therapy other than gastric acid inhibitors known to influence abdominal symptoms (e.g. prokineticum, opioids).
•8.Any disease associated with a severe gastrointestinal dysmotility (e.g. long lasting diabetes mellitus, sclerodermia).

发起方

Fundación para la Investigación en Enfermedades del Aparato Digestivo