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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastroesophageal Reflux Disease, GERD, Reflux Esophagitis

Intervention / Treatment
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* Drug: esomeprazole 20 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: esomeprazole 20 mg<br>esomeprazole 20 mg | Drug: esomeprazole 20 mg<br>* esomeprazole 20 mg once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 4 weeks | 
| 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. | Baseline and 4 weeks. | 
| 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. | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esomeprazole 20mg, heartburn, rabeprazole 10mg, reflux esophagitis, Phase IV