Optimizing treatment of maldigestion in patients with chronic pancreatitis

• Conditions: Patients diagnosed of chronic pancreatitis with pancreatic exocrine insufficiency under pancreatic enzyme replacement therapy; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-002570-20-ES
• Lead Sponsor: Department of gastroenterology. University Hospital of Santiago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-18
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <29%.
3. Written informed consent
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified