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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 is currently recruiting participants.
Verified by AstraZeneca, November 2008
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00786773
  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

MedlinePlus related topics: GERD
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Epidemiological Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 2055
Study Start Date: September 2008
Estimated Study Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786773

Contacts
Contact: AstraZeneca Vietnam Clinical Study Information 84-8-3827 8088 vanphuc.le@astrazeneca.com

Locations
Vietnam
Research Site Not yet recruiting
Ca mau, Vietnam
Research Site Not yet recruiting
Can Tho, Vietnam
Research Site Not yet recruiting
Danang, Vietnam
Research Site Not yet recruiting
Haiphong, Vietnam
Research Site Not yet recruiting
Thai binh, Vietnam
Research Site Recruiting
HCMC, Vietnam
Research Site Not yet recruiting
My Tho, Vietnam
Research Site Not yet recruiting
Nam dinh, Vietnam
Research Site Recruiting
Hanoi, Vietnam
Vietnam, An giang
Research Site Not yet recruiting
Long xuyen, An giang, Vietnam
Vietnam, Binh dinh
Research Site Not yet recruiting
Qui nhon, Binh dinh, Vietnam
Vietnam, Dac Lac
Research Site Not yet recruiting
Ban Me Thuot, Dac Lac, Vietnam
Vietnam, Dong Nai
Research Site Not yet recruiting
Bien Hoa, Dong Nai, Vietnam
Research Site Not yet recruiting
Thong nhat, Dong Nai, Vietnam
Vietnam, Dong Thap
Research Site Not yet recruiting
Cao Lanh, Dong Thap, Vietnam
Research Site Not yet recruiting
Sa Dec, Dong Thap, Vietnam
Vietnam, Khanh hoa
Research Site Not yet recruiting
Nha trang, Khanh hoa, Vietnam
Vietnam, Thua thien Hue
Research Site Not yet recruiting
Hue, Thua thien Hue, 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

Responsible Party: AstraZeneca Pharmaceuticals ( Le Van Phuc )
Study ID Numbers: NIS-GVN-DUM-2008/1
Study First Received: November 5, 2008
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00786773  
Health Authority: Vietnam: Ministry of Health

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

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Pyrosis
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Heartburn
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on January 16, 2009