To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

This study has been completed.
Sponsor:
Collaborator:
Quintiles East Asia Pte. Ltd.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01249651
First received: November 26, 2010
Last updated: October 1, 2012
Last verified: June 2012
Results First Received: June 8, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heartburn
Intervention: Drug: esomeprazole 40 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
First participant enrolled on 23 November 2010. Last participant completed on 11 June 2011. Out of 101 enrolled participants, 100 participants (target was 100) received esomeprazole 40 mg. All of the participants were included in safety analysis set and 96 out of the 100 participants were included in the full analysis set for efficacy analyses.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a history of reflux oesophagitis and with continuing heartburn after previous treatment with rabeprazole 20 mg were included in this study.

Reporting Groups
  Description
Esomeprazole 40 mg esomeprazole 40 mg once daily, 8 weeks

Participant Flow:   Overall Study
    Esomeprazole 40 mg  
STARTED     101 [1]
COMPLETED     94 [2]
NOT COMPLETED     7  
Withdrawal by Subject                 4  
Adverse Event                 1  
Protocol Violation                 1  
Sponsor Decision                 1  
[1] Enrolled
[2] Completed the 8-week treatment period



  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.
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Reporting Groups
  Description
Esomeprazole 40 mg esomeprazole 40 mg once daily, 8 weeks

Baseline Measures
    Esomeprazole 40 mg  
Number of Participants  
[units: participants]
  101  
Age  
[units: Year]
Mean ± Standard Deviation
  51.2  ± 13.71  
Gender  
[units: Participants]
 
Female     41  
Male     60  



  Outcome Measures
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1.  Primary:   Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)   [ Time Frame: Baseline to 8 weeks ]

2.  Secondary:   Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)   [ Time Frame: Baseline and 4 weeks ]

3.  Secondary:   Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)   [ Time Frame: Baseline and 4 weeks ]

4.  Secondary:   Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)   [ Time Frame: Baseline to 8 weeks ]


  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: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01249651     History of Changes
Other Study ID Numbers: D961HL00001
Study First Received: November 26, 2010
Results First Received: June 8, 2012
Last Updated: October 1, 2012
Health Authority: Korea: Food and Drug Administration
Taiwan : Food and Drug Administration
China: Food and Drug Administration