Double-blind, multicenter, randomized, placebo-controlled, parallel-group study to investigate the effect of Creon 25 000 Minimicrospheres on body mass index (BMI) in patients after gastrectomy.
- Conditions
- Patients atleast 18 years old with total or subtotal gastrektomy.
- Registration Number
- EUCTR2004-005012-80-FI
- Lead Sponsor
- Solvay Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
*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
*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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method