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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Reflux Esophagitis; Gastroesophageal Reflux Disease; GERD

Treatments: Drug: esomeprazole 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01397084

D961HL00002

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

esomeprazole 20 mg

Other group

Description:

esomeprazole 20 mg

Treatment:

Drug: esomeprazole 20 mg