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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-01-31

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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease GERD Reflux Esophagitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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esomeprazole 20 mg

Group Type OTHER

esomeprazole 20 mg

Intervention Type DRUG

esomeprazole 20 mg once daily for 8 weeks

Interventions

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esomeprazole 20 mg

esomeprazole 20 mg once daily for 8 weeks

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No