Gastrectomy Study: Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy
NCT ID: NCT00160186
Last Updated: 2008-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2003-12-31
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Pancreatin
2 capsules Pancreatin with 25 000 lipase units per main meal (3 meals) and 1 capsule per snack (2-3 snacks)
2
Placebo
Placebo
Interventions
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Pancreatin
2 capsules Pancreatin with 25 000 lipase units per main meal (3 meals) and 1 capsule per snack (2-3 snacks)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* Progressive tumors/metastasis
* Complications leading to insufficient peroral nutrition
* Known allergy to pancreatin
* Known exocrine insufficiency
* Experimental drug intake
18 Years
ALL
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
Responsible Party
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Solvay Pharmaceuticals
Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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Site 9
Odense, , Denmark
Site 10
Tampere, , Finland
Site 1
Bergen, , Norway
Site 2
Fredrikstad, , Norway
Site 3
Tromsø, , Norway
Site 5
Linköping, , Sweden
Site 7
Malmo, , Sweden
Site 6
Stockholm, , Sweden
Site 8
Stockholm, , Sweden
Countries
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Other Identifiers
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S245.4.007
Identifier Type: -
Identifier Source: org_study_id