Clinical trial NCT00152399: Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding
Official title: 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]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peptic Ulcer
Keywords: Peptic ulcer bleeding, upper intestinal bleeding, endoscopy, somatostatin
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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

Primary outcomes:
measure: 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 outcomes:
measure: To evaluate the difference between somatostatin and placebo on the following variables; Type of failure; Time to failure(h) up to 72 hours; Mortality
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Angers
country: France
city: Bobigny Cedex
country: France
city: Creteil
country: France
city: Paris
country: France
city: Villejuif
country: France
city: Athens
country: Greece
city: Crete-Hellas
country: Greece
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Kaposvar
country: Hungary
city: Vac
country: Hungary
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Pruszkow
country: Poland
city: Warsaw
country: Poland
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: UCB Pharma
name: Tatiana Kharkevitch, MD
role: STUDY_DIRECTOR
References: