- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01635959
Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Tract Symptoms in Egypt (GERD Q NIS)
October 2, 2014 updated by: AstraZeneca
The purpose of this study is to calculate the prevalence of gastroesophageal reflux disease (GERD) by mean of GERD-Q questionnaire in patients with upper gastrointestinal tract symptoms in Egypt.
Study Overview
Status
Completed
Detailed Description
Prevalence of Gastroesophageal reflux disease (GERD) in patients with upper gastrointestinal tract symptoms in Egypt
Study Type
Observational
Enrollment (Actual)
3170
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
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Al MENIA, Egypt
- Research Site
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Alex, Egypt
- Research Site
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Asuit, Egypt
- Research Site
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Aswan, Egypt
- Research Site
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Banha, Egypt
- Research Site
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Cairo, Egypt
- Research Site
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Domiaat, Egypt
- Research Site
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Hurghada, Egypt
- Research Site
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Ismailia, Egypt
- Research Site
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Kafr el-Sheikh, Egypt
- Research Site
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Kalubia, Egypt
- Research Site
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Luxor, Egypt
- Research Site
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Mahala, Egypt
- Research Site
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Mansoura, Egypt
- Research Site
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Menofia, Egypt
- Research Site
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Port-Saeed, Egypt
- Research Site
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Qena, Egypt
- Research Site
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Sharkiah, Egypt
- Research Site
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Sohag, Egypt
- Research Site
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Suiz, Egypt
- Research Site
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Tanta, Egypt
- Research Site
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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
Non-Probability Sample
Study Population
Community patients
Description
Inclusion Criteria:
- 18 years and above
- Attending the medical office and reporting symptoms suggestive of upper gastrointestinal tract symptoms such as heartburn/regurgitation, abdominal pain, bloating, belching and nausea/vomiting.
Exclusion Criteria:
- Participating on a clinical trial during the last 3 months.
- Patients not able to read and/or understand the GERD-Q questionnaire.
- Patients already included in the study in other participating site.
- Patients taking PPIs or H2blockers in the l
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 |
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Patients with Gastrointestinal Trackt Symptoms
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of patients scoring ≥ 8 in GERD-Q
Time Frame: baseline
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Percentage of patients scoring ≥ 8 in GERD-Q will be considered as suffering from GERD. The GERD-Q is a potentially useful tool for family practitioners and other health care professionals in diagnosing and managing GERD without initial specialist referral or endoscopy. The Egyptian-validated version of the GERD-Q will be used for the study purposes. |
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD)
Time Frame: baseline
|
Descriptive analysis of socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD) in Egypt.
|
baseline
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Treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD)
Time Frame: baseline
|
Descriptive analysis of treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD) in Egypt.
|
baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dina A Ahmed, MD
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
July 1, 2012
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
July 3, 2012
First Submitted That Met QC Criteria
July 9, 2012
First Posted (Estimate)
July 10, 2012
Study Record Updates
Last Update Posted (Estimate)
October 3, 2014
Last Update Submitted That Met QC Criteria
October 2, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-GEG-XXX-2012/1
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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