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A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00627016
First received: February 21, 2008
Last updated: April 25, 2011
Last verified: April 2011
History of Changes
Results First Received: March 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux
Interventions: Drug: Dexlansoprazole
Drug: Placebo

  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
Subjects were enrolled at 33 investigative sites in the United States from 07 March 2008 to 20 March 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects eligible for entry into the Treatment Period were randomized into one of two, once-daily (QD) treatment groups.

Reporting Groups
  Description
Placebo Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole 30 mg QD Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.

Participant Flow:   Overall Study
    Placebo     Dexlansoprazole 30 mg QD  
STARTED     153     152  
COMPLETED     147     146  
NOT COMPLETED     6     6  
Adverse Event                 1                 1  
Protocol Violation                 0                 2  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 2                 1  
Failed Inclusion/Exclusion Criteria                 0                 1  
Lack of Efficacy                 1                 0  
Placed on Excluded Drugs                 1                 0  
Pregnancy                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole 30 mg QD Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Dexlansoprazole 30 mg QD     Total  
Number of Participants  
[units: participants]
 		  153     152     305  
Age, Customized  
[units: participants]
 		     
<45 years     75     75     150  
45 to <65 years     76     75     151  
>=65 years     2     2     4  
Age  
[units: years]
Mean ± Standard Deviation 		  43.9  ± 12.45     44.6  ± 11.29     44.2  ± 11.87  
Gender  
[units: participants]
 		     
Female     98     97     195  
Male     55     55     110  
Region of Enrollment  
[units: participants]
 		     
United States     153     152     305  
Number of Days with Night Heartburn [1]
[units: participants]
 		     
0-3 days     10     3     13  
4-5 days     36     38     74  
6-7 days     107     111     218  
Number of Nights with Sleep Disturbances Related to Gastroesophageal Reflux Disease (GERD) Symptoms [1]
[units: participants]
 		     
0-3 Nights     40     33     73  
4-5 Nights     53     47     100  
6-7 Nights     60     72     132  
[1] Baseline diary data were summarized using the non-missing diary entries from Study Day -8 to -2, inclusive.



  Outcome Measures
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1.  Primary:   Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.   [ Time Frame: 4 Weeks ]
  Show Outcome Measure 1

2.  Secondary:   Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.   [ Time Frame: Last 7 days of treatment ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.   [ Time Frame: Last 7 days of treatment ]
  Show Outcome Measure 3


  Serious Adverse Events
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Time Frame Adverse events summarized were reported after the first dose of study drug and no more than 30 days after the last dose.
Additional Description Most frequent events are those High Level Terms occurring in at least 5 % of subjects in at least one treatment group.

Reporting Groups
  Description
Placebo Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole 30 mg QD Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.

Serious Adverse Events
    Placebo     Dexlansoprazole 30 mg QD  
Total, serious adverse events      
# participants affected / at risk     1/153 (0.65%)     0/152 (0.00%)  
Pregnancy, puerperium and perinatal conditions      
Abortions Spontaneous † 1    
# participants affected / at risk     1/153 (0.65%)     0/152 (0.00%)  
# events     1     0  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.2)




  Other Adverse Events
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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.


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: Sr. VP Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:


Responsible Party: Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00627016     History of Changes
Other Study ID Numbers: T-GD07-170, U1111-1113-9537
Study First Received: February 21, 2008
Results First Received: March 18, 2010
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration