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A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)

NCT ID: NCT00734097

Last Updated: 2012-10-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Keywords

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heartburn reflux proton pump inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nexium 40 mgs

Group Type EXPERIMENTAL

Esomeprazole 40 mg

Intervention Type DRUG

Once a day

Physical Exam

Intervention Type PROCEDURE

every visit

Quality of Life Questionnaires

Intervention Type OTHER

every visit

pregnancy test, if applicable

Intervention Type PROCEDURE

as needed

Interventions

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Esomeprazole 40 mg

Once a day

Intervention Type DRUG

Physical Exam

every visit

Intervention Type PROCEDURE

Quality of Life Questionnaires

every visit

Intervention Type OTHER

pregnancy test, if applicable

as needed

Intervention Type PROCEDURE

Other Intervention Names

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Nexium

Eligibility Criteria

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Inclusion Criteria

* Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
* informed consent
* over 18 years of age

Exclusion Criteria

* Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
* More than 1 other course of PPI treatment in the previous 12 month
* previous use of esomeprazole
* presence of alarm symptoms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Buenos Aires, , Argentina

Site Status

Research Site

Santiago, , Chile

Site Status

Research Site

Temuco, , Chile

Site Status

Research Site

Viña del Mar, , Chile

Site Status

Research Site

Barranquilla, , Colombia

Site Status

Research Site

Bogotá, , Colombia

Site Status

Research Site

Medellín, , Colombia

Site Status

Research Site

Barquisimeto, , Venezuela

Site Status

Research Site

Caracas, , Venezuela

Site Status

Research Site

San Cristóbal, , Venezuela

Site Status

Countries

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Argentina Chile Colombia Venezuela

Other Identifiers

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NEON

Identifier Type: -

Identifier Source: secondary_id

D9612L00116

Identifier Type: -

Identifier Source: org_study_id