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

December 6, 2010 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2091

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • 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
        • Research Site
    • An giang
      • Long xuyen, An giang, Vietnam
        • Research Site
    • Binh dinh
      • Qui nhon, Binh dinh, Vietnam
        • Research Site
    • Dac Lac
      • Ban Me Thuot, Dac Lac, Vietnam
        • Research Site
    • Dong Nai
      • Bien Hoa, Dong Nai, Vietnam
        • Research Site
      • Thong nhat, Dong Nai, Vietnam
        • Research Site
    • Dong Thap
      • Cao Lanh, Dong Thap, Vietnam
        • Research Site
      • Sa Dec, Dong Thap, Vietnam
        • Research Site
    • Khanh hoa
      • Nha trang, Khanh hoa, Vietnam
        • Research Site
    • Thua thien Hue
      • Hue, Thua thien Hue, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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 …)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
GERD patients who will be treated for GERD with PPI, H2RA, antacid, prokinetics, combination therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Type, frequency and severity of the GERD symptoms
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

December 7, 2010

Last Update Submitted That Met QC Criteria

December 6, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GVN-DUM-2008/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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