Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  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
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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  Limitations and Caveats
  Hide 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.


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


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
phone: 1625 518062 ext +44
e-mail: aztrial_results_posting@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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