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

September 17, 2012 updated by: UCB Pharma

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]

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

370

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
      • Leuven, Belgium
      • Liege, Belgium
  • France
      • Angers, France
      • Bobigny Cedex, France
      • Creteil, France
      • Paris, France
      • Villejuif, France
  • Greece
      • Athens, Greece
      • Crete-Hellas, Greece
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Gyor, Hungary
      • Kaposvar, Hungary
      • Vac, Hungary
  • Poland
      • Bydgoszcz, Poland
      • Krakow, Poland
      • Pruszkow, Poland
      • Warsaw, Poland
  • Spain
      • Alicante, Spain
      • Barcelona, Spain
      • Madrid, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Investigators

  • Study Director: Tatiana Kharkevitch, MD, UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (ACTUAL)

October 1, 2005

Study Completion (ACTUAL)

October 1, 2005

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (ESTIMATE)

September 9, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2012

Last Update Submitted That Met QC Criteria

September 17, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9823

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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