Optimizing treatment of maldigestion in patients with chronic pancreatitis

• Register: EUCTR
• Last refreshed on: 25 April 2016
• Main ID: EUCTR2015-002570-20-ES
• Date of registration: 18/04/2016
• Prospective Registration: No
• Primary sponsor: Department of gastroenterology. University Hospital of Santiago
• Public title: Optimizing treatment of maldigestion in patients with chronic pancreatitis
• Scientific title: Open label, randomized, crossover clinical trial to evaluate the efficacy of increasing doses of pancreatic enzymes against inhibition of acid gastric secretion in patients with exocrine pancreatic insufficiency secondary to chronic pancreatitis
• Date of first enrolment: 25/02/2016
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002570-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Spain

Contacts

• Name: Clinical Trials Information
• Affiliation: Dpt. of Gastroenterology. university Hospital of Santiago

• Name: Clinical Trials Information
• Affiliation: Dpt. of Gastroenterology. university Hospital of Santiago

Key inclusion & exclusion 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 <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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients diagnosed of chronic pancreatitis with pancreatic exocrine insufficiency under pancreatic enzyme replacement therapy

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: Kreon 25000
Product Name: Creon 25000
Product Code: PL 00512/0150
Pharmaceutical Form: Capsule

Primary Outcome(s)

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.

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)

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: At the end of the study

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At the end of the study

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)

Secondary ID(s)

AD-05-013

Source(s) of Monetary Support

Dpt. of Gastroenterology. University Hospital of Santiago