Patients atleast 18 years old with total or subtotal gastrektomy.
Conditions
Interventions
Trade Name: Creon enterocapsule
Pharmaceutical Form:
INN or Proposed INN: pancreatinum
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Solvay Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Signed informen consent. *Male or female at least 18 years old. *Patients with total or subtotal (Roux-en-Y anastomosis) gastrctomy. *Negative pregnancy test during prestudy. *Women with child-bearing potential must be using a medically acceptable method of birth control throughout the study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: *Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT, dermatologic/connective tissue, muscoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric diseases, allergy or major surgery or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which might limit participation in or completion of the study. *Sign of progressive tumours including metastasis. *Complications after gastrectomy which temporarily lead ti insufficient per oral nutrition. *Known allergy of pancreatin. *Known diagnosis of pancreatic exocrine insufficiency due to e.g. chronic pancreatitis or cystic fibrosis or pancreatectomy. *Any type of chronic organic intestinal disease, e.g. Morbus Crohn, Colitis ulcerosa. *Intake of an experimental drug within 4 weeks prior to entry into the study. *Excessive alcohol or drug abuse. *Unwilligness to participate and/or signed informed consent. *Suspected non-compliance or non cooperation. *Any other lack of fitness, in the investigator´s opinion, to participate in or to complete the tudy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the change from baseline to last value in the body mass index (BMI) after 6 months therapy with pancreatic enzyme supplementation (Creon 25 000 Minimicrospheres) versus placebo in patients after gastrectomy. ;Secondary Objective: To investigate the effect of pancreatic enzyme supplementation (Creon 25 000 Minimicrospheres ) on body composition, on stool fat, on the coefficient of fat absorption, stool weight, clinical global impression of disease symptoms quality of life (Qol), clinical symptoms (gastrointestinal) and the data from the diary (stool frquency, stool consistency, abdominal pain, flatulence, appetite). Elastase will be measured to investigate the status of pancreatic exocrine insufficiency.;Primary end point(s): | — |
Countries
Finland
Outcome results
None listed