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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152399
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : September 18, 2012
Information provided by (Responsible Party):
UCB Pharma

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.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Drug: Somatostatin UCB (drug) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 Start Date : September 2000
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. To evaluate the difference between somatostatin and placebo on the following variables; Type of failure; Time to failure(h) up to 72 hours; Mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00152399

Bruxelles, Belgium
Leuven, Belgium
Liege, Belgium
Angers, France
Bobigny Cedex, France
Creteil, France
Paris, France
Villejuif, France
Athens, Greece
Crete-Hellas, Greece
Budapest, Hungary
Debrecen, Hungary
Gyor, Hungary
Kaposvar, Hungary
Vac, Hungary
Bydgoszcz, Poland
Krakow, Poland
Pruszkow, Poland
Warsaw, Poland
Alicante, Spain
Barcelona, Spain
Madrid, Spain
Sponsors and Collaborators
UCB Pharma
Study Director: Tatiana Kharkevitch, MD UCB Pharma

Responsible Party: UCB Pharma Identifier: NCT00152399     History of Changes
Other Study ID Numbers: 9823
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by UCB Pharma:
Peptic ulcer bleeding, upper intestinal bleeding, endoscopy, somatostatin

Additional relevant MeSH terms:
Peptic Ulcer
Gastrointestinal Hemorrhage
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs