Gastrectomy Study: Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastrectomy
Intervention: Pancreatin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
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.
Clinical Details
Official title: Double-Blind, Multicenter, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Baseline-adjusted body mass index (BMI) after 6 months therapy
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Site 9, Odense, Denmark
Site 10, Tampere, Finland
Site 1, Bergen, Norway
Site 2, Frederikstad, Norway
Site 3, Tromso, Norway
Site 5, Linköping, Sweden
Site 6, Stockholm, Sweden
Site 7, Malmo, Sweden
Site 8, Stockholm, Sweden
Additional Information
Starting date: December 2003
Ending date: May 2006
Last updated: March 28, 2008
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