Patients diagnosed of chronic pancreatitis with pancreatic exocrine insufficiency under pancreatic enzyme replacement therapy
Conditions
Interventions
Trade Name: Kreon 25000
Product Name: Creon 25000
Product Code: PL 00512/0150
Pharmaceutical Form: Capsule
Sponsors
Department of gastroenterology. University Hospital of Santiago
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic Pancreatitis diagnosed by CT scan, endoscopy ultrasound (EUS) or MRI 2. Pancreatic exocrine insufficiency diagnosed at inclusion by the 13C-MTG breath test and defined as a 13C-CCR =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age < 18 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. Any kind of uncured malignant disease. 5. Need of any therapy known to influence pancreatic secretion (e.g. somatostatin and somatostatin analogs). 6. Impossibility to stop the treatment with gastric acid inhibitors 7. Any disease associated with a severe gastrointestinal dysmotility (e.g. long lasting diabetes mellitus, sclerodermia). 8. Any kind of gastrointestinal or pancreatic surgery except appendicectomy or cholecistectomy 9. Any experimental drug consumption in the four weeks prior to study entry 10. Any kind of liver disease, celiac disease, inflammatory bowel disease or any other concomitant disease potentially affecting digestion or intestinal absorption. 11. Any kind of severe restrictive lung disease which could potentially alter the result of the pancreatic function breath test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To evaluate the efficacy of increasing the doses of pancreatic enzymes against the inhibition of gastric acid secretion in patients with fat maldigestion despite of the treatment with conventional dose of pancreatic enzyme 2. To evaluate whether there is a direct relationship between dose and response in the treatment of patients with pancreatic exocrine insufficiency.;Secondary Objective: Not applicable;Primary end point(s): Absolute increase in fat digestion as measured by the 13C-CCR breath test with each treatment (A vs B vs C vs D);Timepoint(s) of evaluation of this end point: At the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Difference of fat digestion as measured by 13C-CCR breath test from basal to treatment A 2. Percentage of patients who normalize the 13C-CCR breath test with each treatment (A vs B vs C vs D) 3. Percentage of patients with pancreatic exocrine insufficiency despite of being under the standard treatment (treatment A) 4. Percentage of patients with pancreatic exocrine insufficiency despite of being under the highest doses of enzymes (treatment D) 5. Difference in fat digestion as measured by 13C-CCR breath test between different treatments (A vs B vs C vs D) 6. Difference in fat digestion as measured by 13C-CCR breath test with treatments B and C in patients with pancreatic exocrine insufficiency despite of the treatment standard (treatment A) and in patients who normalize the digestion with treatment A 7. Difference in fat digestion as measured by 13C-CCR breath test with treatment D, compared to treatments B and C. 8. Correlation between the initial 13C-CCR breath test (severity of pancreatic exocrine insufficiency) and the doses of pancreatic enzymes required to normalize the 13C-CCR breath test 9. Establish a cutoff for the 13C-MTG breath test in patients who require higher doses of pancreatic enzymes. 10. Difference in symptoms and quality of life between different treatments (A vs B vs C vs D) 11. Short term adverse events between different treatment ( A vs B vs C vs D);Timepoint(s) of evaluation of this end point: At the end of the study | — |
Countries
Spain
Contacts
Public ContactClinical Trials Information
Dpt. of Gastroenterology. university Hospital of Santiago
Outcome results
None listed