Reflux Esophagitis Phase III Study (Initial Treatment)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00633932
First received: March 4, 2008
Last updated: December 2, 2010
Last verified: December 2010
Results First Received: December 10, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Reflux Esophagitis
Interventions: Drug: Esomeprazole
Drug: Omeprazole

  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 subject enrolled on 11 December 2007. Last subject completed on 12 December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 602 enrolled subjects, 572 subjects were randomised and 30 subjects were not randomised. The reasons of no randomisation were 'Incorrect enrollment' (25 subjects) and 'Voluntary discontinuation by Subject' (5 subjects).

Reporting Groups
  Description
Experimental: Esomeprazole 40mg Esomeprazole 40mg once daily
Experimental: Esomeprazole 20mg Esomeprazole 20mg once daily
Comparator: Omeprazole 20mg Omeprazole 20mg once daily

Participant Flow:   Overall Study
    Experimental: Esomeprazole 40mg     Experimental: Esomeprazole 20mg     Comparator: Omeprazole 20mg  
STARTED     191 [1]   190 [1]   191 [1]
COMPLETED     179     176     180  
NOT COMPLETED     12     14     11  
Adverse Event                 1                 3                 4  
Withdrawal by Subject                 3                 9                 1  
Lost to Follow-up                 1                 0                 2  
Protocol Violation                 5                 2                 3  
Physician Decision                 0                 0                 1  
Doctor's judgement                 1                 0                 0  
Moved Away                 1                 0                 0  
[1] Randomised



  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
Experimental: Esomeprazole 40mg Esomeprazole 40mg once daily
Experimental: Esomeprazole 20mg Esomeprazole 20mg once daily
Comparator: Omeprazole 20mg Omeprazole 20mg once daily
Total Total of all reporting groups

Baseline Measures
    Experimental: Esomeprazole 40mg     Experimental: Esomeprazole 20mg     Comparator: Omeprazole 20mg     Total  
Number of Participants  
[units: participants]
  191     190     191     572  
Age, Customized  
[units: Participants]
       
< 65 years     127     135     126     388  
65 - 74 years     47     36     44     127  
>= 75 years     16     18     20     54  
Missing     1     1     1     3  
Gender, Customized  
[units: Participants]
       
Male     139     137     134     410  
Female     51     52     56     159  
Missing     1     1     1     3  



  Outcome Measures
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1.  Primary:   Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification".   [ Time Frame: 8 weeks ]

2.  Secondary:   Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


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


No publications provided


Responsible Party: Tore Lind / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00633932     History of Changes
Other Study ID Numbers: D961HC00002
Study First Received: March 4, 2008
Results First Received: December 10, 2009
Last Updated: December 2, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency