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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
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 of Continous Infusion of Esomeprazole or Placebo [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinically Significant Rebleeding Within 7 Days [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
Clinically Significant Rebleeding Within 30 Days [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
Death Within 72 Hours [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
Death Within 30 Days [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
Death Related to Rebleeding Within 30 Days as Judged by the EpC [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
Requirement for Surgery Within 72 Hours [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
Requirement for Surgery Within 30 Days [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
Requirement for Endoscopic Re-treatment Within 72 Hours [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
Requirement for Endoscopic Re-treatment Within 30 Days [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
Number of Blood Units Transfused Within 72 Hours [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
Number of Blood Units Transfused Within 30 Days [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]

Enrollment:	1312
Study Start Date:	October 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (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:

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kuipers EJ, Sung JJ, Barkun A, Mössner J, Jensen D, Stuart R, Lau JY, Ahlbom H, Lind T, Kilhamn J. Safety and tolerability of high-dose intravenous esomeprazole for prevention of peptic ulcer rebleeding. Adv Ther. 2011 Feb;28(2):150-9. Epub 2010 Dec 15.

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.

ClinicalTrials.gov Identifier:	NCT00251979 History of Changes
Other Study ID Numbers:	D961DC00001
Study First Received:	November 9, 2005
Results First Received:	December 12, 2008
Last Updated:	May 18, 2011
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Stomach Diseases

Hemostatics
Omeprazole
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012