To Assess the Efficacy of Esomeprazole 40 mg 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 40 mg to subjects who still had heartburn after receiving rabeprazole 20 mg once daily for 4 to 8 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 40 mg Once Daily in Subjects With Continuing Symptoms of Heartburn Following Treatment With a Previous Rabeprazole.

Conditions
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Heartburn

Intervention / Treatment
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* Drug: esomeprazole 40 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 20 years or more Documented history of reflux esophagitis verified by endoscopy in the past, including the grade of Los Angeles (LA) classification (Lundell LR et al 1999) before treatment Ongoing (until date of Visit 1) treatment with rabeprazole 20 mg, given once daily, for a period of 4 to 8 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 during the past 7 days prior to Visit 1, judged by the investigator(s) as follows: At least 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities) OR At least 4 days with symptoms including mild ones (i.e. awareness of sign or symptom, but easily tolerated). The subject needs to be able to understand and read the official languages of the country. Exclusion Criteria: Use of other PPIs and/or H2RA during rabeprazole treatment Previous use of esomeprazole 40 mg during the 12 weeks before enrolment Current or historical evidence of gastrointestinal pathology History, signs or symptoms of clinically significant or uncontrolled cardiovascular, pulmonary, renal, endocrine, hematologic, neurologic, psychiatric pancreatic or hepatic disease as judged by the investigator to interfere with the conduct of the study, the interpretation of study results, subject compliance, or the health of the subject during the study. Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or pyloroplasty, hiatus hernia surgery or fundoplication. Note: endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection or simple suturing of an ulcer are not exclusion criteria.

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: 1<br>One arm: esomeprazole 40 mg | Drug: esomeprazole 40 mg<br>* esomeprazole 40 mg once daily, 8 weeks<br>* Other names: No comparator;|

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 to 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 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 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 Frequency 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 Frequency 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 to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients, Single