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
Results First Received: December 12, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
Condition: Gastrointestinal Hemorrhage
Intervention: Drug: Esomeprazole

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Esomeprazole Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Participant Flow:   Overall Study
    Esomeprazole     Placebo  
STARTED     375 [1]   389 [1]
COMPLETED     337     349  
NOT COMPLETED     38     40  
Protocol Violation                 3                 5  
Adverse Event                 11                 17  
Withdrawal by Subject                 13                 7  
Lost to Follow-up                 8                 6  
Death                 3                 5  
[1] ITT population



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Esomeprazole Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Total Total of all reporting groups

Baseline Measures
    Esomeprazole     Placebo     Total  
Number of Participants  
[units: participants]
  375     389     764  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     182     210     392  
>=65 years     193     179     372  
Gender  
[units: Participants]
     
Female     121     121     242  
Male     254     268     522  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo   [ Time Frame: Within 72 hours ]

2.  Secondary:   Clinically Significant Rebleeding Within 7 Days   [ Time Frame: Within 7 days ]

3.  Secondary:   Clinically Significant Rebleeding Within 30 Days   [ Time Frame: Within 30 days ]

4.  Secondary:   Death Within 72 Hours   [ Time Frame: Within 72 hours ]

5.  Secondary:   Death Within 30 Days   [ Time Frame: Within 30 days ]

6.  Secondary:   Death Related to Rebleeding Within 30 Days as Judged by the EpC   [ Time Frame: Within 30 days ]

7.  Secondary:   Requirement for Surgery Within 72 Hours   [ Time Frame: Within 72 hours ]

8.  Secondary:   Requirement for Surgery Within 30 Days   [ Time Frame: Within 30 days ]

9.  Secondary:   Requirement for Endoscopic Re-treatment Within 72 Hours   [ Time Frame: Within 72 hours ]

10.  Secondary:   Requirement for Endoscopic Re-treatment Within 30 Days   [ Time Frame: Within 30 days ]

11.  Secondary:   Number of Blood Units Transfused Within 72 Hours   [ Time Frame: Within 72 hours ]

12.  Secondary:   Number of Blood Units Transfused Within 30 Days   [ Time Frame: within 30 days ]

13.  Secondary:   Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period   [ Time Frame: Within 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

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