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The purpose of this study is to investigate BMI and the nutritional parameters of Creon (pancreatin) versus placebo after a total or subtotal gastrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatin | Drug | 2 capsules Pancreatin with 25 000 lipase units per main meal (3 meals) and 1 capsule per snack (2-3 snacks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-adjusted body mass index (BMI) after 6 months therapy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 9 | Odense | Denmark | ||||
| Site 10 |
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| Placebo | Drug | Placebo |
|
| Tampere |
| Finland |
| Site 1 | Bergen | Norway |
| Site 2 | Fredrikstad | Norway |
| Site 3 | Tromsø | Norway |
| Site 5 | Linköping | Sweden |
| Site 7 | Malmö | Sweden |
| Site 6 | Stockholm | Sweden |
| Site 8 | Stockholm | Sweden |
| ID | Term |
|---|---|
| D010194 | Pancreatin |
| ID | Term |
|---|---|
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010184 | Pancreatic Extracts |
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |
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