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

Peptic Ulcer Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152399
• Other study ID #: 9823
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: September 17, 2012
• Start date: September 2000
• Est. completion date: October 2005

Study information

• Verified date: September 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicines and Health Products, FAMHPGreece: National Organization of MedicinesSpain: Spanish Agency of MedicinesHungary: National Institute of PharmacyPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage

Intervention

Drug:
• Somatostatin UCB (drug)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Belgium,  France,  Greece,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the difference between somatostatin and placebo on the following variables; Type of failure; Time to failure(h) up to 72 hours; Mortality