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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 Global Research & Development Center, Inc.
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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  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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  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