Diagnosis and Response to Treatment Using a Reliable Gastroesophageal Reflux Disease (GERD) Questionnaire: An In Clinical Practice Study (GQS)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00963144
First received: August 12, 2009
Last updated: October 20, 2010
Last verified: October 2010
  Purpose

The purpose of the study is to determine the applicability and utility of Gerd Q in the diagnosis of GERD and in the assessment of treatment response.


Condition
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis and Response to Treatment Using a Reliable Gerd Questionnaire-an In Clinical Practise Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To determine the applicability and utility of Gerd Q in the diagnosis of GERD and assessment of treatment response [ Time Frame: The applicability and utility of the Gerd Questionnaire will be done on 2 vists- Day 1 and Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess and monitor the treatment response of patients diagnosed with GERD [ Time Frame: The monitoring and assessment of treatment response using the Gerd Questionnaire will be done on 2 vists-Day 1 and Day 30 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Patients of either gender aged between 18-79 years of age
  • Patients must be having symptoms of gastroesophageal reflux disease

Exclusion Criteria:

  • None
  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: NCT00963144

Locations
Malaysia
Research Site
Kuala Lumpur, Malaysia
Research Site
Selangor, Malaysia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Goh Khean Lee, MBBS, MRCP, FRCP Faculty of Medicine, University of Malaya Medical Center (UMMC),
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00963144     History of Changes
Other Study ID Numbers: NIS-GMY-DUM-2009/1
Study First Received: August 12, 2009
Last Updated: October 20, 2010
Health Authority: Malaysia: Ministry of Health

Keywords provided by AstraZeneca:
Gerd Questionnaire

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

ClinicalTrials.gov processed this record on August 18, 2014