Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial To Study The Efficacy And The Safety Of The Early Administration Of Somatostatin (Ucb) 12 Mg/24 H IV Infusion And Two IV Boluses Of 250 Mcg During 72 Hours In The Treatment Of Subjects With Acute Severe Upper Gastrointestinal Bleeding (UGIB) With Suspicion Of Peptic Ulcer Bleeding [The PUB Study]

Conditions
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Peptic Ulcer

Intervention / Treatment
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* Drug: Somatostatin UCB (drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Somatostatin UCB (drug)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peptic ulcer bleeding, upper intestinal bleeding, endoscopy, somatostatin