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NCT00786773 Clinical Trial

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

Gastroesophageal Reflux Disease Clinical Trial

Official title:
Epidemiological Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00786773
Other study ID # NIS-GVN-DUM-2008/1
Secondary ID
Status Completed
Phase N/A
First received November 5, 2008
Last updated December 6, 2010
Start date October 2008
Est. completion date June 2009

Study information
Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Vietnam: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 2091
Est. completion date June 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 …)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Vietnam Research Site Ban Me Thuot Dac Lac
Vietnam Research Site Bien Hoa Dong Nai
Vietnam Research Site Ca mau
Vietnam Research Site Can Tho
Vietnam Research Site Cao Lanh Dong Thap
Vietnam Research Site Danang
Vietnam Research Site Haiphong
Vietnam Research Site Hanoi
Vietnam Research Site Hcmc
Vietnam Research Site Hue Thua thien Hue
Vietnam Research Site Long xuyen An giang
Vietnam Research Site My Tho
Vietnam Research Site Nam dinh
Vietnam Research Site Nha trang Khanh hoa
Vietnam Research Site Qui nhon Binh dinh
Vietnam Research Site Sa Dec Dong Thap
Vietnam Research Site Thai binh
Vietnam Research Site Thong nhat Dong Nai

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Vietnam, 

Outcome
Type Measure Description Time frame Safety issue
Primary Type, frequency and severity of the GERD symptoms 4 weeks No
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