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Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669811
First Posted: August 21, 2012
Last Update Posted: August 27, 2015
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: May 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Refractory Reflux Esophagitis
Interventions: Drug: Esomeprazole (D961H) twice daily
Drug: Esomeprazole (D961H) once daily

  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 25 August 2012. Last subject completed on 30 May 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 1398 enrolled subjects, 287 subjects were randomised and 1111 subjects were not randomised. The reasons of no randomisation were 'Eligibilty criteria not met' (1067 subjects), 'Subject decision' (37 subjects), 'Adverse event' (2 subjects) and other reasons (5 subjects).

Reporting Groups
  Description
D961H 20 mg BID Hard capsule containing 22.3 mg of D961H as enteric coated pellets
D961H 20 mg QD + Placebo Hard capsule unidentifiable to D961H capsule 20 mg

Participant Flow:   Overall Study
    D961H 20 mg BID   D961H 20 mg QD + Placebo
STARTED   145   142 
COMPLETED   142   131 
NOT COMPLETED   3   11 
Investigator decision                0                1 
Withdrawal by Subject                1                2 
Adverse Event                2                6 
Eligibility Criteria Not Fulfilled                0                2 



  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.
It was found that 2 patients in D961H 20 mg QD + Placebo group had no refractory RE after randomisation. Therefore, these two patients were excluded from the full analysis set, which was the primary analysis set of this study and was used for summaries of baseline characteristics and outcome measures.

Reporting Groups
  Description
D961H 20 mg BID D961H 20 mg twice Daily
D961H 20 mg QD + Placebo D961H 20 mg once daily along with placebo
Total Total of all reporting groups

Baseline Measures
   D961H 20 mg BID   D961H 20 mg QD + Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 145   140   285 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.7  (13.87)   61.7  (14.72)   63.2  (14.35) 
Age, Customized 
[Units: Participants]
     
<65   68   69   137 
>=65   77   71   148 
Gender 
[Units: Participants]
     
Female   69   70   139 
Male   76   70   146 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   145   140   285 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification   [ Time Frame: 8 Weeks ]

2.  Secondary:   Percentage of Participants With Healing of RE Who Were Graded "O" at Week 4 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification   [ Time Frame: 4 Weeks ]

3.  Secondary:   Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4   [ Time Frame: 4 Weeks ]

4.  Secondary:   Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4   [ Time Frame: 4 Weeks ]

5.  Secondary:   Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4   [ Time Frame: 4 Weeks ]

6.  Secondary:   Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4   [ Time Frame: 4 Weeks ]

7.  Secondary:   Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4   [ Time Frame: 4 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: Masahiro Nii
Organization: Clinical Statistics & Programming Department, Clinical Science Division, R&D, AstraZeneca Japan
e-mail: Masahiro.Nii@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01669811     History of Changes
Other Study ID Numbers: D961UC00002
First Submitted: August 17, 2012
First Posted: August 21, 2012
Results First Submitted: May 18, 2015
Results First Posted: August 14, 2015
Last Update Posted: August 27, 2015