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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000375-42 |
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This trial discontinued March 7,2009 due to high screen failure rate.
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This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| Recombinant Microbial Lipase SLV339 |
| Measure | Description | Time Frame |
|---|---|---|
| CFA (Coefficient of Fat Absorption) | from baseline to end of 7 days treatment |
| Measure | Description | Time Frame |
|---|---|---|
| CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology | from baseline to end of 7 days treatment |
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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 4206 | Brno | Czechia | ||||
| Site 4203 |
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| Drug |
oral, 150 mg/d, 7 days treatment |
|
| Recombinant Microbial Lipase SLV339 | Drug | oral, 300 mg/d, 7 days treatment |
|
| Recombinant Microbial Lipase SLV339 | Drug | oral, 600 mg/d, 7 days treatment |
|
| Hradec Králové |
| Czechia |
| Site 4202 | Prague | Czechia |
| Site 4205 | Prague | Czechia |
| Site 4201 | Tábor | Czechia |
| Site 4204 | Ústí nad Orlicí | Czechia |
| Site 4503 | Herning | Denmark |
| Site 4502 | Hvidovre | Denmark |
| Site 4501 | Odense | Denmark |
| Site 3612 | Békéscsaba | Hungary |
| Site 3607 | Budapest | Hungary |
| Site 3614 | Budapest | Hungary |
| Site 3615 | Debrecen | Hungary |
| Site 3602 | Dunaújváros | Hungary |
| Site 3610 | Eger | Hungary |
| Site 3604 | Gyula | Hungary |
| Site 3606 | Pécs | Hungary |
| Site 3613 | Sopron | Hungary |
| Site 3609 | Szeged | Hungary |
| Site 3601 | Szekszárd | Hungary |
| Site 3611 | Szentes | Hungary |
| Site 3608 | Tatabánya | Hungary |
| Site 3603 | Vác | Hungary |
| Site 3605 | Zalaegerszeg | Hungary |
| Site 3702 | Daugavpils | Latvia |
| Site 3701 | Riga | Latvia |
| Site 3703 | Riga | Latvia |
| Site 3704 | Riga | Latvia |
| Site 3705 | Riga | Latvia |
| Site 4808 | Bialystok | Poland |
| Site 4809 | Gdansk | Poland |
| Site 4810 | Gdansk | Poland |
| Site 4805 | Katowice | Poland |
| Site 4811 | Lodz | Poland |
| Site 4807 | Poznan | Poland |
| Site 4814 | Poznan | Poland |
| Site 4802 | Skierniewice | Poland |
| Site 4804 | Sopot | Poland |
| Site 4801 | Warsaw | Poland |
| Site 4806 | Warsaw | Poland |
| Site 4812 | Wroclaw | Poland |
| Site 4813 | Wroclaw | Poland |
| Site 0901 | Moscow | Russia |
| Site 0904 | Moscow | Russia |
| Site 0908 | Moscow | Russia |
| Site 0909 | Moscow | Russia |
| Site 0910 | Moscow | Russia |
| Site 4602 | Gothenburg | Sweden |
| Site 4603 | Stockholm | Sweden |
| Site 4601 | Umeå | Sweden |
| ID | Term |
|---|---|
| D010188 | Exocrine Pancreatic Insufficiency |
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D010195 | Pancreatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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