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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00999063
Other study ID # NIS-GTH-NEX-2009/1
Secondary ID
Status Completed
Phase N/A
First received October 20, 2009
Last updated March 30, 2011
Start date December 2009
Est. completion date February 2011

Study information

Verified date March 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical CommitteeThailand: Food and Drug AdministrationThailand: Khon Kaen University Ethics Committee for Human ResearchThailand: Ministry of Public Health
Study type Observational

Clinical Trial Summary

This is a prospective , epidemiological, multi-centre, phase IV study, approximately 5,000 patients who suffer with upper gastrointestinal tract symptoms. Each patient will be assessed for GERD with GerdQ Thai Version.


Recruitment information / eligibility

Status Completed
Enrollment 4108
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Provision of informed consent prior to any study specific procedures

- Female or male aged at least 18 years

- Patient must be having symptoms suggestive of upper gastrointestinal tract symptoms such as heart burn/ regurgitation

Exclusion Criteria:

- Involvement in the planning and /or conduct of the study (applies to both AstraZeneca staff and /or staff at study site

- Participation in a clinical study(excluding non-interventional study or registry) during the last 3 months

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Research Site Bangkok Noi Bangkok
Thailand Research Site Klong Luang Pathumthani
Thailand Research Site Maerim Chiang Mai
Thailand Research Site Maung Chiang Mai
Thailand Research Site Maung Khon Kaen
Thailand Research Site Maung Nakhon Sri Thammarat
Thailand Research Site Maung Nakhonratchasima
Thailand Research Site Maung Nakhonsawan
Thailand Research Site Maung Nakornpathom
Thailand Research Site Maung Phetchabun
Thailand Research Site Maung Phuket
Thailand Research Site Maung Rajburi
Thailand Research Site Maung Roiet
Thailand Research Site Maung Samut sakorn
Thailand Research Site Maung Sukhothai
Thailand Research Site Maung Trang
Thailand Research Site Maung Ubonratchathani
Thailand Research Site Maung Uttaradit
Thailand Research Site Muang Udon Thani
Thailand Research Site Muang Bangkok
Thailand Research Site Muang Nonthaburi
Thailand Research Site Pathumwan Bangkok
Thailand Research Site Rajthevee Bangkok
Thailand Research Site Ratchthewi Bangkok
Thailand Research Site Varin Chamrap Ubonratchathani

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of gastroesophageal reflux disease (GERD) in patients presented with upper gastrointestinal tract symptoms No
Secondary Response to various treatments for patients who have been diagnosed of GERD No