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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
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


  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 ]

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 ]

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 ]


  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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