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Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

NCT ID: NCT00206024

Last Updated: 2010-11-19

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

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-07-31

Brief Summary

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This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.

Detailed Description

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Conditions

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Heartburn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Esomeprazole magnesium (Nexium)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent
* A history of heartburn for at least 6 months
* A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy
* A positive esophageal acid perfusion test
* At least 3 days of 'moderate' severity heartburn over the previous 7 days
* No use of any acid suppression therapy (PPI, H2RA, etc.) within 14 days of randomization

Exclusion Criteria

* A history of gastric or esophageal surgery
* H. pylori positive
* A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization
* Currently taking higher than the standard approved proton pump inhibitor doses
* Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Nexium Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Tucson, Arizona, United States

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Anaheim, California, United States

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Orange, California, United States

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San Diego, California, United States

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Washington D.C., District of Columbia, United States

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DeLand, Florida, United States

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Miami, Florida, United States

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New Smyrna Beach, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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New Orleans, Louisiana, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Hollywood, Maryland, United States

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Attleboro, Massachusetts, United States

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Hackensack, New Jersey, United States

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Vineland, New Jersey, United States

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Rochester, New York, United States

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Asheville, North Carolina, United States

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Elkin, North Carolina, United States

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Guthrie, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Christiansburg, Virginia, United States

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Ponce, , Puerto Rico

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Countries

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United States Puerto Rico

Other Identifiers

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D9612L00064

Identifier Type: -

Identifier Source: org_study_id