Patients 2 weeks after discharge from the hospital after an attack of acute necrotizing pancreatitis
Conditions
Interventions
Trade Name: Kreon 25.000
Product Name: Creon 25000
Product Code: PL 00512/0150
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Fundación para la Investigación en Enfermedades del Aparato Digestivo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1. Age 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superior efficacy of pancreatic enzymes over placebo in improving fat digestion in subjects suffering from PEI after an attack of acute necrotizing pancreatitis. The primary efficacy parameter will be the change in the 13C-cumulative recovery rate (CRR) from baseline to treatment as evaluated by the 13C-MTG breath test;Secondary Objective: 1. To investigate the incidence of PEI after acute necrotizing pancreatitis and the potential factors increasing the risk of PEI, among them age, etiology, extent and location of the necrosis, complications such as ductal disruption, pseudocyst, abscess, and need for surgical or endoscopic necrosectomy. 2. To evaluate the effect of PERT compared to placebo on abdominal symptoms (abdominal pain, distention and discomfort, postprandial fullness, early satiety, meteorism, bloating, stool frequency and consistency, flatulence), quality of life (QoL SF-36 and EORT QLQ-C30) and nutritional status (hematologic and biochemical nutritional parameters). 3. To evaluate the safety and tolerability of PERT, including vital signs, safety laboratory values and adverse events.;Primary end point(s): Difference in fat digestion as measured by the 13C-MTG breath test (13C-CCR) from basal to therapy (PERT or placebo).;Timepoint(s) of evaluation of this end point: Four weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in symptoms, QoL and nutritional status between PERT and placebo at month 1 (symptoms), 3 and 6 after randomization.;Timepoint(s) of evaluation of this end point: Three and six months | — |
Countries
Spain
Contacts
Public ContactJ. Enrique Domínguez Muñoz
Fundación para la Investigación en Enfermedades del Aparato Digestivo
Outcome results
None listed