Gastroesophageal Reflux DiseaseGQSNCT00963144
Diagnosis and Response to Treatment Using a Reliable Gastroesophageal Reflux Disease (GERD) Questionnaire: An In Clinical Practice Study
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 2 sites in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 250 participants
- Where
- 2 sitesMalaysia
- Study dates
- Jul 2009to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patients of either gender aged between 18-79 years of age
- Patients must be having symptoms of gastroesophageal reflux disease
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Diagnosis and Response to Treatment Using a Reliable Gerd Questionnaire-an In Clinical Practise Study
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.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gerd Questionnaire
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the applicability and utility of Gerd Q in the diagnosis of GERD and assessment of treatment response
Measured: The applicability and utility of the Gerd Questionnaire will be done on 2 vists- Day 1 and Day 30
Secondary outcomes (1)
To assess and monitor the treatment response of patients diagnosed with GERD
Measured: The monitoring and assessment of treatment response using the Gerd Questionnaire will be done on 2 vists-Day 1 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Goh Khean Lee, MBBS, MRCP, FRCP, Principal investigator, Faculty of Medicine, University of Malaya Medical Center (UMMC),
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963144
- Sponsor's protocol ID
- NIS-GMY-DUM-2009/1
- Acronym
- GQS
- Status last verified
- Oct 2010
- First submitted
- 12 Aug 2009
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Response to Treatment Using a Reliable Gerd Questionnaire-an In Clinical Practise Study
- ClinicalTrials.gov ID
- NCT00963144
- Acronym / sponsor ID
- GQS / NIS-GMY-DUM-2009/1
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gerd Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Patients of either gender aged between 18-79 years of age
- Patients must be having symptoms of gastroesophageal reflux disease
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goh Khean Lee, MBBS, MRCP, FRCP principal investigator
Faculty of Medicine, University of Malaya Medical Center (UMMC),
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2010.