Status:
COMPLETED
Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding
Lead Sponsor:
UCB Pharma
Conditions:
Peptic Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU.
- 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
- Treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy.
- 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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT00152399
Start Date
September 1 2000
End Date
October 1 2005
Last Update
September 18 2012
Active Locations (22)
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1
Brussels, Belgium
2
Leuven, Belgium
3
Liège, Belgium
4
Angers, France