Efficacy of Esomeprazole in Patients With Frequent Heartburn (NEXT2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01370538
First received: June 1, 2011
Last updated: March 1, 2013
Last verified: March 2013
Results First Received: October 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Heartburn
Intervention: Drug: Esomeprazole

  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
From total of 526 screened subjects, 341 subjects were randomised. From 341 subjects 170 and 171 were allocated to Esomeprazole and Placebo respectively.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Esomeprazole Esomeprazole magnesium trihydrate 22.3 mg
Placebo Placebo for Esomeprazole

Participant Flow:   Overall Study
    Esomeprazole     Placebo  
STARTED     170     171  
Patients Who Received Treatment     165     161  
Patients Who Completed Treatment     151     152  
COMPLETED     151     152  
NOT COMPLETED     19     19  
Voluntary Discontinuation by Subject                 3                 2  
Eligibility criteria not fulfilled                 0                 1  
Adverse Event                 1                 0  
Protocol Violation                 8                 5  
Development of study specific withdrawal                 1                 1  
Lost to follow up                 6                 10  



  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
Esomeprazole Esomeprazole magnesium trihydrate 22.3 mg
Placebo Placebo for Esomeprazole
Total Total of all reporting groups

Baseline Measures
    Esomeprazole     Placebo     Total  
Number of Participants  
[units: participants]
  170     171     341  
Age  
[units: Years]
Mean ± Standard Deviation
     
All     41.6  ± 14.0     42.8  ± 13.2     42.2  ± 13.6  
Gender  
[units: Participants]
     
Female     91     87     178  
Male     79     84     163  
Race/Ethnicity, Customized  
[units: Participants]
     
WHITE     111     120     231  
BLACK OR AFRICAN AMERICAN     52     50     102  
NATIVE HAWAIIAN/PACIFIC ISLANDER     1     0     1  
AMERICAN INDIAN/ALASKA NATIVE     3     0     3  
OTHER     3     1     4  
Race/Ethnicity, Customized  
[units: Participants]
     
HISPANIC OR LATINO     24     25     49  
NOT HISPANIC OR LATINO     55     46     101  
NOT REPORTED     91     100     191  



  Outcome Measures
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1.  Primary:   Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment   [ Time Frame: From randomisation to day 14 ]

2.  Primary:   Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment   [ Time Frame: From randomisation to day 14 ]

3.  Secondary:   Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period   [ Time Frame: From randomisation to the day 14 ]

4.  Secondary:   Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo   [ Time Frame: From randomisation to day 14 ]

5.  Secondary:   Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment   [ Time Frame: From randomisation to day 14 ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
phone: 1625 518062 ext +44
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01370538     History of Changes
Other Study ID Numbers: D961RC00002
Study First Received: June 1, 2011
Results First Received: October 19, 2012
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration