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

Condition(s) targeted: Gastroesophageal Reflux Disease; GERD; Reflux Esophagitis

Intervention: esomeprazole 20 mg (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Masataka Date, Study Director, Affiliation: AZ K.K.
Makiko Abe, Study Chair, Affiliation: AZ K.K

Overall contact:
AstraZeneca Japan, Email: Masataka.Date@astrazeneca.com

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: 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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To assess the efficacy of esomeprazole 20 mg once daily in subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks

Secondary outcome:

To assess the efficacy of esomeprazole 20 mg

To assess the efficacy of esomeprazole 20 mg by evaluating the changes in the maximum severity of heartburn during the 7-day period prior to the 4 week visit

To assess the safety and tolerability of esomeprazole 20 mg by evaluating of adverse events (AEs)

To assess the safety and tolerability of esomeprazole 20 mg by evaluating of vital signs (blood pressure and pulse rate).

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

AstraZeneca Japan, Email: Masataka.Date@astrazeneca.com

Starting date: July 2011
Last updated: July 18, 2011