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To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatostatin UCB (drug) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy and safety of the early IV administration of somatostatin during 72 hours compared to placebo in the control of acute severe UGIB with suspicion of PUB by measuring the failure rate |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the difference between somatostatin and placebo on the following variables; Type of failure; Time to failure(h) up to 72 hours; Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatiana Kharkevitch, MD | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels | Belgium | |||||
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| Leuven |
| Belgium |
| Liège | Belgium |
| Angers | France |
| Bobigny | France |
| Créteil | France |
| Paris | France |
| Villejuif | France |
| Athens | Greece |
| Crete-Hellas | Greece |
| Budapest | Hungary |
| Debrecen | Hungary |
| Győr | Hungary |
| Kaposvár | Hungary |
| Vác | Hungary |
| Bydgoszcz | Poland |
| Krakow | Poland |
| Pruszków | Poland |
| Warsaw | Poland |
| Alicante | Spain |
| Barcelona | Spain |
| Madrid | Spain |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D010438 | Peptic Ulcer Hemorrhage |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D006471 | Gastrointestinal Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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