Status:
COMPLETED
Gastrectomy Study: Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Gastrectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00160186
Start Date
December 1 2003
End Date
May 1 2006
Last Update
March 31 2008
Active Locations (9)
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1
Site 9
Odense, Denmark
2
Site 10
Tampere, Finland
3
Site 1
Bergen, Norway
4
Site 2
Fredrikstad, Norway