A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00251979

Purpose

This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

Condition	Intervention	Phase
Gastrointestinal Hemorrhage	Drug: Esomeprazole	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomised, Double-Blind, Parallel-Group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Gastrointestinal Bleeding Peptic Ulcer

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Clinically significant rebleeding within 72 hours

Secondary Outcome Measures:

Clinically significant rebleeding within 7 and 30 days
Death within 72 hours and 30 days
Death related to rebleeding within 30 days
Requirement for surgery within 72 hours and 30 days
Requirement for endoscopic re-treatment within 72 hours and 30 days
Number of blood units transfused within 72 hours and 30 days
Number of days hospitalized due to rebleeding during the 30-day treatment period
Adverse events, clinical laboratory findings, physical examination, vital signs including BP and pulse

Estimated Enrollment:	760
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signs of a bleeding in the stomach
One endoscopically confirmed bleeding ulcer in the stomach or duodenum

Exclusion Criteria:

Malignancy or other advanced disease.
Major cardiovascular event.
Severe hepatic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251979

Show 79 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	AstraZeneca Nexium Medical Sciences Director	AstraZeneca
Principal Investigator:	Joseph Sung, MD	Chinese University of Hong Kong

More Information

Additional Information:

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Sung JJ, Barkun A, Kuipers EJ, Mössner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. Epub 2009 Feb 16.

Study ID Numbers:	D961DC00001
Study First Received:	November 9, 2005
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00251979 History of Changes
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Hemorrhage
Intestinal Diseases
Pharmacologic Actions

Digestive System Diseases
Pathologic Processes
Stomach Diseases
Therapeutic Uses
Peptic Ulcer Hemorrhage
Anti-Ulcer Agents
Peptic Ulcer
Duodenal Diseases

ClinicalTrials.gov processed this record on February 08, 2010