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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00152399
First received: September 7, 2005
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Peptic Ulcer
Drug: Somatostatin UCB (drug)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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]

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

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

Estimated Enrollment: 370
Study Start Date: September 2000
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152399

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
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Tatiana Kharkevitch, MD UCB, Inc.
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00152399     History of Changes
Other Study ID Numbers: 9823
Study First Received: September 7, 2005
Last Updated: September 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Greece: National Organization of Medicines
Spain: Spanish Agency of Medicines
Hungary: National Institute of Pharmacy
Poland: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014