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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: November 5, 2008
Last updated: December 6, 2010
Last verified: December 2010
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.

Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Epidemiological Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Type, frequency and severity of the GERD symptoms [ Time Frame: 4 weeks ]

Enrollment: 2091
Study Start Date: October 2008
Study Completion Date: June 2009
GERD patients who will be treated for GERD with PPI, H2RA, antacid, prokinetics, combination therapy


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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 …)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00786773

Research Site
Long xuyen, An giang, Vietnam
Research Site
Qui nhon, Binh dinh, Vietnam
Research Site
Ban Me Thuot, Dac Lac, Vietnam
Research Site
Bien Hoa, Dong Nai, Vietnam
Research Site
Thong nhat, 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
Hue, Thua thien Hue, Vietnam
Research Site
Ca mau, Vietnam
Research Site
Can Tho, Vietnam
Research Site
Danang, Vietnam
Research Site
Haiphong, Vietnam
Research Site
Hanoi, Vietnam
Research Site
Hcmc, Vietnam
Research Site
My Tho, Vietnam
Research Site
Nam dinh, Vietnam
Research Site
Thai binh, Vietnam
Sponsors and Collaborators
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
  More Information

Responsible Party: Le Van Phuc, AstraZeneca Pharmaceuticals Identifier: NCT00786773     History of Changes
Other Study ID Numbers: NIS-GVN-DUM-2008/1
Study First Received: November 5, 2008
Last Updated: December 6, 2010

Keywords provided by AstraZeneca:
reflux symptom
acid regurgitation

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on May 25, 2017