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

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.
 
ClinicalTrials.gov Identifier: NCT00251979
Recruitment Status : Completed
First Posted : November 11, 2005
Results First Posted : June 17, 2011
Last Update Posted : June 17, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 9, 2005
First Posted Date  ICMJE November 11, 2005
Results First Submitted Date  ICMJE December 12, 2008
Results First Posted Date  ICMJE June 17, 2011
Last Update Posted Date June 17, 2011
Study Start Date  ICMJE October 2005
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2011)
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo [ Time Frame: Within 72 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2005)
Clinically significant rebleeding within 72 hours
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2011)
  • Clinically Significant Rebleeding Within 7 Days [ Time Frame: Within 7 days ]
  • Clinically Significant Rebleeding Within 30 Days [ Time Frame: Within 30 days ]
  • Death Within 72 Hours [ Time Frame: Within 72 hours ]
  • Death Within 30 Days [ Time Frame: Within 30 days ]
  • Death Related to Rebleeding Within 30 Days as Judged by the EpC [ Time Frame: Within 30 days ]
  • Requirement for Surgery Within 72 Hours [ Time Frame: Within 72 hours ]
  • Requirement for Surgery Within 30 Days [ Time Frame: Within 30 days ]
  • Requirement for Endoscopic Re-treatment Within 72 Hours [ Time Frame: Within 72 hours ]
  • Requirement for Endoscopic Re-treatment Within 30 Days [ Time Frame: Within 30 days ]
  • Number of Blood Units Transfused Within 72 Hours [ Time Frame: Within 72 hours ]
  • Number of Blood Units Transfused Within 30 Days [ Time Frame: within 30 days ]
  • Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period [ Time Frame: Within 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
Official Title  ICMJE 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.
Brief Summary This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Gastrointestinal Hemorrhage
Intervention  ICMJE Drug: Esomeprazole
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2011)
1312
Original Enrollment  ICMJE
 (submitted: November 9, 2005)
760
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   Netherlands,   Norway,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Turkey,   United Kingdom
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT00251979
Other Study ID Numbers  ICMJE D961DC00001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Nexium Medical Sciences Director AstraZeneca
Principal Investigator: Joseph Sung, MD Chinese University of Hong Kong
PRS Account AstraZeneca
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP