Back to resultsTo 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
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
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
NCT ID
NCT01397084
First Posted
July 18, 2011
Last Updated
February 18, 2013
Sponsor
AstraZeneca
Collaborators
Parexel
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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