Text Size

Reflux Esophagitis Phase III Study (Maintenance Treatment)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00634114
First received: March 4, 2008
Last updated: May 18, 2010
Last verified: May 2010
History of Changes
Results First Received: May 18, 2010  
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
  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
Enrolment 8Jan08-19May09. 564 randomised participants, 563 in Full Analysis set and safety analysis set. FAS used for summaries of baseline characteristics and efficacy. SAS for summaries of safety. 1 pt. in Omep. 10 mg excluded as they took no investigational drug. Nos. for gender were 188 in Esom. 20 mg, 188 in Esom. 10 mg and 187 in Omep. 20 mg.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 578 enrolled participants, 564 participants were randomised and 14 participants were not randomised. The reasons of no randomisation were 'Incorrect enrolment' (11 participants) and 'Voluntary discontinuation by participant' (3 participants).

Reporting Groups
  Description
Experimental: Esomeprazole 20 mg Esomeprazole 20 mg once daily
Experimental: Esomeprazole 10 mg Esomeprazole 10 mg once daily
Comparator: Omeprazole 10 mg Omeprazole 10 mg once daily

Participant Flow:   Overall Study
    Experimental: Esomeprazole 20 mg     Experimental: Esomeprazole 10 mg     Comparator: Omeprazole 10 mg  
STARTED     188 [1]   189 [1]   187 [1]
COMPLETED     160 [2]   154 [2]   148 [2]
NOT COMPLETED     28     35     39  
Adverse Event                 6                 8                 3  
Withdrawal by Subject                 9                 6                 11  
Lost to Follow-up                 0                 0                 1  
Protocol Violation                 3                 3                 1  
Pregnancy                 1                 0                 0  
Incorrect enrolment                 0                 1                 0  
Recurrence of reflux esophagitis                 5                 15                 21  
Difficult to continue                 3                 1                 1  
Other reason                 1                 1                 1  
[1] Randomised
[2] Completed



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Experimental: Esomeprazole 20 mg Esomeprazole 20 mg once daily
Experimental: Esomeprazole 10 mg Esomeprazole 10 mg once daily
Comparator: Omeprazole 10 mg Omeprazole 10 mg once daily
Total Total of all reporting groups

Baseline Measures
    Experimental: Esomeprazole 20 mg     Experimental: Esomeprazole 10 mg     Comparator: Omeprazole 10 mg     Total  
Number of Participants  
[units: participants]
 		  188     189     187     564  
Age, Customized  
[units: Participants]
 		       
<65     131     131     137     399  
65-74     45     41     38     124  
>=75     12     16     12     40  
Missing     0     1     0     1  
Gender, Customized [1]
[units: Participants]
 		       
Female     46     51     42     139  
Male     142     147     145     434  
Missing     0     1     0     1  
[1] 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.   [ Time Frame: Up to 24 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment   [ Time Frame: up to 4 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment   [ Time Frame: Up to 12 weeks ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
Measure Description Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.
Time Frame Up to 12 weeks  
Safety Issue No  

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 20 mg Esomeprazole 20 mg once daily
Experimental: Esomeprazole 10 mg Esomeprazole 10 mg once daily
Comparator: Omeprazole 10 mg Omeprazole 10 mg once daily

Measured Values
    Experimental: Esomeprazole 20 mg     Experimental: Esomeprazole 10 mg     Comparator: Omeprazole 10 mg  
Number of Participants Analyzed  
[units: participants]
 		  188     188     187  
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment  
[units: Participants]
 		  179     172     163  

No statistical analysis provided for Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  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.


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: NCT00634114     History of Changes
Other Study ID Numbers: D961HC00006
Study First Received: March 4, 2008
Results First Received: May 18, 2010
Last Updated: May 18, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency