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To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

Primary Purpose

Gastroesophageal Reflux Disease, GERD, Reflux Esophagitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
esomeprazole 20 mg
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring esomeprazole 20mg, heartburn, rabeprazole 10mg, reflux esophagitis, Phase IV

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male of female aged 20 years or more
  • History of reflux esophagitis
  • Ongoing (until date of Visit 1) treatment with rabeprazole 10 mg, given once daily, for at least 4 weeks.The subject must take rabeprazole at least 4 days a week in the past 7 days prior to Visit 1.
  • Persisting symptoms of heartburn experienced at least 2 days during the past 7 days prior to Visit 1.

Exclusion Criteria:

  • Use of other PPIs and/or H2RA during rabeprazole treatment
  • History or having other gastrointestinal diseases
  • History of upper gastrointestinal surgery
  • Initiation of medications that can affect digestive functions within 4 weeks before study treatment
  • Inability to complete questionnaires

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    esomeprazole 20 mg

    Arm Description

    esomeprazole 20 mg

    Outcomes

    Primary Outcome Measures

    Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
    The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.

    Secondary Outcome Measures

    Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
    The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.
    Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
    Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".
    Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
    Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".

    Full Information

    First Posted
    July 18, 2011
    Last Updated
    February 18, 2013
    Sponsor
    AstraZeneca
    Collaborators
    Parexel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01397084
    Brief Title
    To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
    Official Title
    An 8-week, Open Label, Multicentre Study to Assess the Efficacy of Esomeprazole 20 mg Once Daily in Subjects With Continuing Symptoms of Heartburn Following Treatment With a Previous Rabeprazole
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    January 2012 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AstraZeneca
    Collaborators
    Parexel

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant improvement of heartburn after 8-week treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux Disease, GERD, Reflux Esophagitis
    Keywords
    esomeprazole 20mg, heartburn, rabeprazole 10mg, reflux esophagitis, Phase IV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    107 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    esomeprazole 20 mg
    Arm Type
    Other
    Arm Description
    esomeprazole 20 mg
    Intervention Type
    Drug
    Intervention Name(s)
    esomeprazole 20 mg
    Intervention Description
    esomeprazole 20 mg once daily for 8 weeks
    Primary Outcome Measure Information:
    Title
    Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
    Description
    The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.
    Time Frame
    Baseline and 8 weeks
    Secondary Outcome Measure Information:
    Title
    Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
    Description
    The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.
    Time Frame
    Baseline and 4 weeks
    Title
    Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
    Description
    Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".
    Time Frame
    Baseline and 4 weeks.
    Title
    Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
    Description
    Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".
    Time Frame
    Baseline and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male of female aged 20 years or more History of reflux esophagitis Ongoing (until date of Visit 1) treatment with rabeprazole 10 mg, given once daily, for at least 4 weeks.The subject must take rabeprazole at least 4 days a week in the past 7 days prior to Visit 1. Persisting symptoms of heartburn experienced at least 2 days during the past 7 days prior to Visit 1. Exclusion Criteria: Use of other PPIs and/or H2RA during rabeprazole treatment History or having other gastrointestinal diseases History of upper gastrointestinal surgery Initiation of medications that can affect digestive functions within 4 weeks before study treatment Inability to complete questionnaires
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Masataka Date
    Organizational Affiliation
    AZ K.K.
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Makiko Abe
    Organizational Affiliation
    AZ K.K
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

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