Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding
This study has been completed.
Sponsor:
UCB, Inc.
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
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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
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: Directorate general for the protection of Public health: Medicines 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 May 16, 2013