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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01635959
Other study ID # NIS-GEG-XXX-2012/1
Secondary ID
Status Completed
Phase N/A
First received July 3, 2012
Last updated October 2, 2014
Start date July 2012
Est. completion date July 2014

Study information

Verified date October 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Description:

Prevalence of Gastroesophageal reflux disease (GERD) in patients with upper gastrointestinal tract symptoms in Egypt


Recruitment information / eligibility

Status Completed
Enrollment 3170
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Research Site Al MENIA
Egypt Research Site Alex
Egypt Research Site Asuit
Egypt Research Site Aswan
Egypt Research Site Banha
Egypt Research Site Cairo
Egypt Research Site Domiaat
Egypt Research Site Hurghada
Egypt Research Site Ismailia
Egypt Research Site Kafr el-Sheikh
Egypt Research Site Kalubia
Egypt Research Site Luxor
Egypt Research Site Mahala
Egypt Research Site Mansoura
Egypt Research Site Menofia
Egypt Research Site Port-Saeed
Egypt Research Site Qena
Egypt Research Site Sharkiah
Egypt Research Site Sohag
Egypt Research Site Suiz
Egypt Research Site Tanta

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients scoring = 8 in GERD-Q 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 No
Secondary Socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD) Descriptive analysis of socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD) in Egypt. baseline No
Secondary Treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD) Descriptive analysis of treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD) in Egypt. baseline No