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High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757275
First Posted: December 28, 2012
Last Update Posted: March 8, 2016
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.
Information provided by (Responsible Party):
AstraZeneca
Results First Submitted: December 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Bleeding Peptic Ulcer
Interventions: Drug: Esomeprazole Na
Drug: Cimetidine
Drug: Esomeprazole Mg

  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

Overall, 239 patients were enrolled from 19 centres in China. The first patient entered the study on 26 February 2013 and the last patient completed the study on 30 December 2014.

Of the 239 patients enrolled into the study, 222 (92.9%) patients were randomised to treatment.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
17 patients were not assigned to treatment, 15 patients did not fulfil the eligibility criteria, 1 was due to patient decision, and 1 patient due to “other” (not enough experimental drug).

Reporting Groups
  Description
Esomeprazole Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
Cimetidine Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days

Participant Flow:   Overall Study
    Esomeprazole   Cimetidine
STARTED   111   111 
COMPLETED   102   98 
NOT COMPLETED   9   13 
Lost to Follow-up                1                2 
Adverse Event                3                3 
Withdrawal by Subject                2                4 
Not treated                3                4 



  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.
Among 222 randomised patients, 215 patients received iv treatment: 108 patients in the esomeprazole treatment group and 107 patients in the cimetidine treatment group.

Reporting Groups
  Description
Esomeprazole Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
Cimetidine Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
Total Total of all reporting groups

Baseline Measures
   Esomeprazole   Cimetidine   Total 
Overall Participants Analyzed 
[Units: Participants]
 108   107   215 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Age   42.4  (12.79)   41.8  (12.96)   42.1  (12.85) 
Age, Customized 
[Units: Participants]
     
<=65 years   104   103   207 
>65 years   4   4   8 
Gender 
[Units: Participants]
     
Female   25   24   49 
Male   83   83   166 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian/Chinese   108   107   215 
Number of patients with one bleeding ulcer 
[Units: Participants]
 108   107   215 
Forrest class [1] 
[Units: Participants]
     
Ia   5   4   9 
Ib   58   64   122 
IIa   33   24   57 
IIb   12   15   27 
[1] Forrest classification of PUB (Forrest et al 1974): Ia = arterial bleeding; Ib = oozing bleeding; IIa = non-bleeding visible vessel; IIb = adherent clot.
Bleeding ulcer size 
[Units: Mm]
Mean (Standard Deviation)
 8.2  (4.8)   8.1  (3.6)   8.1  (4.3) 
Ulcer location 
[Units: Participants]
     
Stomach   17   8   25 
Duodenum   84   89   173 
Stomach and Duodenum   7   10   17 
Number of patients with ulcers of different sizes 
[Units: Participants]
     
<=2 cm   105   106   211 
>2 cm   3   1   4 
Number of patients with single and multiple ulcers 
[Units: Participants]
     
Single   89   89   178 
Multiple   19   18   37 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Clinically Significant Rebleeding Within 72 Hours   [ Time Frame: 72 hours ]

2.  Secondary:   Rate of Clinically Significant Rebleeding During 7 Days   [ Time Frame: 7 days ]

3.  Secondary:   Rate of Clinically Significant Rebleeding During 30 Days   [ Time Frame: 30 days ]

4.  Secondary:   Number of Patients With Endoscopic Re-treatment Within 72 Hours   [ Time Frame: 72 hours ]

5.  Secondary:   Number of Patients With Endoscopic Re-treatment Within 30 Days   [ Time Frame: 30 days ]

6.  Secondary:   Number of Patients With Surgery Due to Rebleeding Within 72 Hours   [ Time Frame: within 72 hours ]

7.  Secondary:   Number of Patients With Surgery Due to Rebleeding Within 30 Days   [ Time Frame: within 30 days ]

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

9.  Secondary:   Number of Blood Units Transfused Within 30 Days   [ 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
No hypothesis testing was performed in this study and, as such, no formal statistical comparisons were made. Two patients who were initially randomised to receive cimetidine treatment actually received esomeprazole treatment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Huifang Chen
Organization: AstraZeneca
phone: +86 21 60301335
e-mail: ariel.chen@astrazeneca.com


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01757275     History of Changes
Other Study ID Numbers: D961DC00007
First Submitted: December 21, 2012
First Posted: December 28, 2012
Results First Submitted: December 16, 2015
Results First Posted: March 8, 2016
Last Update Posted: March 8, 2016