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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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00786773
First received: November 5, 2008
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

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.


Condition
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 ] [ Designated as safety issue: No ]

Enrollment: 2091
Study Start Date: October 2008
Study Completion Date: June 2009
Groups/Cohorts
1
GERD patients who will be treated for GERD with PPI, H2RA, antacid, prokinetics, combination therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)

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 …)
  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 ClinicalTrials.gov identifier: NCT00786773

Locations
Vietnam
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
AstraZeneca
Investigators
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

No publications provided

Responsible Party: Le Van Phuc, AstraZeneca Pharmaceuticals
ClinicalTrials.gov 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
Health Authority: Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
GERD
reflux symptom
heartburn
acid regurgitation
PPI
H2RA
antacid

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014