Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment.
Epidemiological Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment
1 other identifier
observational
2,091
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
Shorter than P25 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 5, 2008
CompletedFirst Posted
Study publicly available on registry
November 6, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedDecember 7, 2010
December 1, 2010
November 5, 2008
December 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Type, frequency and severity of the GERD symptoms
4 weeks
Study Arms (1)
1
GERD patients who will be treated for GERD with PPI, H2RA, antacid, prokinetics, combination therapy
Eligibility Criteria
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)
You may qualify if:
- Patients with GERD diagnosed clinically or by endoscopy and prescribed with medical treatments
- Provision of written informed consent
You may not qualify if:
- 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 …)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Long Xuyen, An Giang, Vietnam
Research Site
Qui Nhon, Binh Dinh, Vietnam
Research Site
Buon Ma Thuot, Dac Lac, Vietnam
Research Site
Biên Hòa, Dong Nai, Vietnam
Research Site
Thống Nhất, Dong Nai, Vietnam
Research Site
Cao Lanh, Dong Thap, Vietnam
Research Site
Sa Dec, Dong Thap, Vietnam
Research Site
Nha Trang, Khanh Hoa, Vietnam
Research Site
Huế, Thừa Thiên Huế Province, Vietnam
Research Site
Can Tho, Vietnam
Research Site
Cà Mau, Vietnam
Research Site
Da Nang, Vietnam
Research Site
Haiphong, Vietnam
Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Mỹ Tho, Vietnam
Research Site
Nam Định, Vietnam
Research Site
Thái Bình, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ta Long
Vietnam Association of Gastroenterology
- PRINCIPAL INVESTIGATOR
Dao Van Long
Medical University of Hanoi
- PRINCIPAL INVESTIGATOR
Tran Kieu Mien
HCMC Association of Gastroenterology
- PRINCIPAL INVESTIGATOR
Le Thanh Ly
Cho Ray Hospital
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 5, 2008
First Posted
November 6, 2008
Study Start
October 1, 2008
Study Completion
June 1, 2009
Last Updated
December 7, 2010
Record last verified: 2010-12