A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627016
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : May 6, 2010
Last Update Posted : April 28, 2011
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux
Interventions: Drug: Dexlansoprazole
Drug: Placebo

  Participant Flow

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
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 
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

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

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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  More Information