Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding
NCT ID: NCT00152399
Last Updated: 2012-09-18
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
PHASE2
370 participants
INTERVENTIONAL
2000-09-30
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Interventions
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Somatostatin UCB (drug)
Eligibility Criteria
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Inclusion Criteria
* Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...).
* Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia
Exclusion Criteria
* Any treatment with PPIs (IV or per os) within the last 48 hours preceding randomisation.
* Treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days.
* Deficient haemostasis (platelets \< 40 x 109/l, international normalised ratio of the prothrombin time \> 1.5 (or prothrombin time \< 70%), or activated partial thromboplastin time \> 40 seconds (or according to the normal ranges validated, from local lab))
* Anticoagulant therapy (vitamin K antagonists or heparin including LMW heparins)
* Terminal stage illness in which endoscopy is contraindicated
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Tatiana Kharkevitch, MD
Role: STUDY_DIRECTOR
UCB Pharma
Locations
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Brussels, , Belgium
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
Countries
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Other Identifiers
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9823
Identifier Type: -
Identifier Source: org_study_id