Clinical trial NCT00786773: Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment.
Official title: Epidemiological Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
reflux symptom
heartburn
acid regurgitation
PPI
H2RA
antacid
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-06
Enrollment: 2091
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target survey population is existing GERD patients or newly diagnosed GERD patients, who will be treated for GERD with PPI, H2RA, antacid, prokinetics, combination therapy ... at Visit 1 and will come back after 4 weeks for clinical re-assessment (Visit 2)

Brief 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.


Eligibility criteria: 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 ...)

Primary outcomes:
measure: Type, frequency and severity of the GERD symptoms
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Long xuyen
country: Vietnam
facility: Research Site
state: An giang
city: Qui nhon
country: Vietnam
facility: Research Site
state: Binh dinh
city: Ban Me Thuot
country: Vietnam
facility: Research Site
state: Dac Lac
city: Bien Hoa
country: Vietnam
facility: Research Site
state: Dong Nai
city: Thong nhat
country: Vietnam
facility: Research Site
state: Dong Nai
city: Cao Lanh
country: Vietnam
facility: Research Site
state: Dong Thap
city: Sa Dec
country: Vietnam
facility: Research Site
state: Dong Thap
city: Nha trang
country: Vietnam
facility: Research Site
state: Khanh hoa
city: Hue
country: Vietnam
facility: Research Site
state: Thua thien Hue
city: Ca mau
country: Vietnam
facility: Research Site
city: Can Tho
country: Vietnam
facility: Research Site
city: Danang
country: Vietnam
facility: Research Site
city: Haiphong
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Hcmc
country: Vietnam
facility: Research Site
city: My Tho
country: Vietnam
facility: Research Site
city: Nam dinh
country: Vietnam
facility: Research Site
city: Thai binh
country: Vietnam
facility: Research Site
Study officials:
affiliation: Vietnam Association of Gastroenterology
name: Ta Long
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Hanoi
name: Dao Van Long
role: PRINCIPAL_INVESTIGATOR
affiliation: HCMC Association of Gastroenterology
name: Tran Kieu Mien
role: PRINCIPAL_INVESTIGATOR
affiliation: Cho Ray Hospital
name: Le Thanh Ly
role: PRINCIPAL_INVESTIGATOR
References: