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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;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
Condition: Gastrointestinal Hemorrhage
Intervention: Drug: Esomeprazole

  Participant Flow
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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
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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 
Overall Participants Analyzed 
[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
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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
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  More Information
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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


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

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