Gastrectomy Study: Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy
- Registration Number
- NCT00160186
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
The purpose of this study is to investigate BMI and the nutritional parameters of Creon (pancreatin) versus placebo after a total or subtotal gastrectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Informed consent
- Males or females
- Age >= 18 years
- Total or subtotal gastrectomy
- Females having negative pregnancy test or being surgically sterile or 1 year postmenopausal; women of childbearing age must use effective birth control.
Exclusion Criteria
- Diseases or conditions limiting the participation in, or completion of, the study
- Progressive tumors/metastasis
- Complications leading to insufficient peroral nutrition
- Known allergy to pancreatin
- Known exocrine insufficiency
- Experimental drug intake
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Pancreatin - 2 Placebo -
- Primary Outcome Measures
Name Time Method Baseline-adjusted body mass index (BMI) after 6 months therapy 6 months
- Secondary Outcome Measures
Name Time Method Effect on body composition, on stool fat, on the coefficient of fat absorption, stool weight, quality of life (Qol), clinical symptoms (gastrointestinal), data from the diary, Elastase 6 months
Trial Locations
- Locations (9)
Site 6
🇸🇪Stockholm, Sweden
Site 10
🇫🇮Tampere, Finland
Site 9
🇩🇰Odense, Denmark
Site 3
🇳🇴Tromso, Norway
Site 1
🇳🇴Bergen, Norway
Site 5
🇸🇪Linköping, Sweden
Site 2
🇳🇴Frederikstad, Norway
Site 8
🇸🇪Stockholm, Sweden
Site 7
🇸🇪Malmo, Sweden