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

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]

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152399

Enrollment

370

Registered

2005-09-09

Start date

2000-09-30

Completion date

2005-10-31

Last updated

2012-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer

Keywords

Peptic ulcer bleeding, upper intestinal bleeding, endoscopy, somatostatin

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.

Interventions

DRUGSomatostatin UCB (drug)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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	—

Countries

Belgium, France, Greece, Hungary, Poland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026