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Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

NCT ID: NCT00444275

Last Updated: 2012-12-11

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

3029 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-10-31

Brief Summary

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To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.

Detailed Description

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Conditions

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GERD

Keywords

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Gastroesophageal Reflux Disease Acid Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Esomeprazole 20 mg Once Daily (initial phase)

Group Type EXPERIMENTAL

esomeprazole (Nexium®)

Intervention Type DRUG

This randomized study was conducted on parallel groups and included two phases:

* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
* One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Esomeprazole 40 mg Once Daily (initial phase)

Group Type EXPERIMENTAL

esomeprazole (Nexium®)

Intervention Type DRUG

This randomized study was conducted on parallel groups and included two phases:

* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
* One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Esomeprazole 20 mg Once Daily (Maintenance Phase)

Group Type EXPERIMENTAL

esomeprazole (Nexium®)

Intervention Type DRUG

This randomized study was conducted on parallel groups and included two phases:

* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
* One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Esomeprazole 20 mg on Demand (Maintenance Phase)

Group Type EXPERIMENTAL

esomeprazole (Nexium®)

Intervention Type DRUG

This randomized study was conducted on parallel groups and included two phases:

* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
* One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Antacid Treatment (Maintenance Phase)

Group Type EXPERIMENTAL

Xolaam®

Intervention Type DRUG

This randomized study was conducted on parallel groups and included two phases:

* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
* One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Interventions

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esomeprazole (Nexium®)

This randomized study was conducted on parallel groups and included two phases:

* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
* One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Intervention Type DRUG

Xolaam®

This randomized study was conducted on parallel groups and included two phases:

* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
* One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).

Exclusion Criteria

* Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the last 3 months prior to Visit 1.
* A history of severe esophagitis or known other complications, with alarm symptoms
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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

Principal Investigators

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AstraZeneca France Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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EudraCT No: 2006-002867-19

Identifier Type: -

Identifier Source: secondary_id

D9612L00111

Identifier Type: -

Identifier Source: org_study_id