Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2003-02-28

Brief Summary

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A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD) with continued heartburn symptoms with a course of therapy of 30 mg twice daily Lansoprazole.

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Detailed Description

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Conditions

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Heartburn Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

40mg once daily

Group Type EXPERIMENTAL

Esomeprazole Magnesium

Intervention Type DRUG

40mg once daily

2

30mg twice daily

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

30mg twice daily

Interventions

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Esomeprazole Magnesium

40mg once daily

Intervention Type DRUG

Lansoprazole

30mg twice daily

Intervention Type DRUG

Other Intervention Names

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Nexium Prevacid

Eligibility Criteria

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Inclusion Criteria

* Subjects must have reported history of heartburn symptoms whilst on lansoprazole 30 mg twice daily during the 30 days prior to screening.
* Subjects must have a minimal cumulative heartburn score of at least 4 for a minimum of 14 days, where zero = none, one = mild, two = moderate, three = severe.

Exclusion Criteria

* subjects history of esophageal ulcers, esophageal strictures, esophageal neoplasms, gastric or duodenal ulcers, or any other significant gastric or esophageal pathology judged to be clinically significant by the investigator.
* Subjects with persistent heartburn symptoms while on lansoprazole 30 mg twice daily for a period of \> 6 months
* Subjects with a history of severe hepatic insufficiency (specifically, Childs-Pugh Class C liver disease) that may adversely affect the metabolism abd pharmacokinetics of esomeprazole and/or lansoprazole.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No