Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment.

NCT ID: NCT00786773

Last Updated: 2010-12-07

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

Total Enrollment

2091 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-06-30

Brief Summary

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To describe the change of impact of reflux symptoms on the everyday life perceived by patients before and after 4 weeks treatment by using GERD Impact Scale questionnaire (GIS) by total GERD patient population and by treatment group; and to describe the concordance between patient-reported and physician-reported symptom load.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Keywords

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GERD reflux symptom heartburn acid regurgitation PPI H2RA antacid

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

GERD patients who will be treated for GERD with PPI, H2RA, antacid, prokinetics, combination therapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with GERD diagnosed clinically or by endoscopy and prescribed with medical treatments
* Provision of written informed consent

Exclusion Criteria

* Patients cannot read and/or understand GIS
* Patients with the history or symptoms of peptic ulcer, gastrointestinal cancer, serious or malignant diseases (anorexia, weight loss, anemia, fever …)
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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AstraZeneca Pharmaceuticals

Principal Investigators

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Ta Long

Role: PRINCIPAL_INVESTIGATOR

Vietnam Association of Gastroenterology

Dao Van Long

Role: PRINCIPAL_INVESTIGATOR

Medical University of Hanoi

Tran Kieu Mien

Role: PRINCIPAL_INVESTIGATOR

HCMC Association of Gastroenterology

Le Thanh Ly

Role: PRINCIPAL_INVESTIGATOR

Cho Ray Hospital

Locations

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Research Site

Long Xuyen, An Giang, Vietnam

Site Status

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Qui Nhon, Binh Dinh, Vietnam

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Buon Ma Thuot, Dac Lac, Vietnam

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Biên Hòa, Dong Nai, Vietnam

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Thống Nhất, Dong Nai, Vietnam

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Cao Lanh, Dong Thap, Vietnam

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Sa Dec, Dong Thap, Vietnam

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Nha Trang, Khanh Hoa, Vietnam

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Huế, Thừa Thiên Huế Province, Vietnam

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Can Tho, , Vietnam

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Cà Mau, , Vietnam

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Da Nang, , Vietnam

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Haiphong, , Vietnam

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Hanoi, , Vietnam

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Ho Chi Minh City, , Vietnam

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Mỹ Tho, , Vietnam

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Nam Định, , Vietnam

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Thái Bình, , Vietnam

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Countries

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Vietnam

Other Identifiers

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NIS-GVN-DUM-2008/1

Identifier Type: -

Identifier Source: org_study_id