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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00251979
First received: November 9, 2005
Last updated: May 18, 2011
Last verified: May 2011

November 9, 2005
May 18, 2011
October 2005
December 2007   (final data collection date for primary outcome measure)
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
Clinically significant rebleeding within 72 hours
Complete list of historical versions of study NCT00251979 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Gastrointestinal Hemorrhage
Drug: Esomeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1312
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   Netherlands,   Norway,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Turkey,   United Kingdom
 
NCT00251979
D961DC00001
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Nexium Medical Sciences Director AstraZeneca
Principal Investigator: Joseph Sung, MD Chinese University of Hong Kong
AstraZeneca
May 2011

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