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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Intervention: esomeprazole 20 mg (Drug)

Phase: Phase 4

Status: Completed

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

Summary

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.

Clinical Details

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: 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).

Secondary outcome:

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).

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).

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).

Eligibility

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

Locations and Contacts

Additional Information

Starting date: August 2011
Last updated: February 18, 2013

Page last updated: August 23, 2015

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