HEARD (Long Term) Study - Histology of the Esophagus in Acid-Related Disease

NCT ID: NCT00243724

Last Updated: 2009-03-26

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

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-06-30

Brief Summary

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Determine if different levels of acid-suppression with esomeprazole for 6 months on chosen histological markers of esophageal epithelial acid-related disease in patients with upper GI symptoms.

Detailed Description

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Conditions

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Gastroesophageal Reflux Heartburn Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Esomeprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* 18 years or older
* history of upper GI symptoms

Exclusion Criteria

* Peptic ulcer disease
* upper gastrointestinal surgery
* malignancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Canada Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Vancouver, British Columbia, Canada

Site Status

Research Site

Halifax, Nova Scotia, Canada

Site Status

Research Site

Guelph, Ontario, Canada

Site Status

Research Site

Hamilton, Ontario, Canada

Site Status

Research Site

Kingston, Ontario, Canada

Site Status

Research Site

Mississauga, Ontario, Canada

Site Status

Research Site

North York, Ontario, Canada

Site Status

Research Site

Montreal, Quebec, Canada

Site Status

Research Site

Pointe-Claire, Quebec, Canada

Site Status

Research Site

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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D9612L00078

Identifier Type: -

Identifier Source: org_study_id

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