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NCT00697008 Clinical Trial

Asociación Española de Gastroenterologia (Spanish Gastroenterology Association) Gastroesophageal Reflux Disease Guideline - Prospective Study

GERD Clinical Trial

— Prospect  

Official title:
Symptomatic Assessment and Therapeutic Outcomes in Typical GERD Patients Following a New CP Guideline in the Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00697008
Other study ID # NIS-GES-DUM-2007/3
Secondary ID
Status Completed
Phase N/A
First received June 4, 2008
Last updated February 9, 2009
Start date December 2007

Study information
Verified date February 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical Trial Summary

To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP Guideline.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 17 Years and older
Eligibility Inclusion Criteria:

- Signed informed consent

- Age above 18

- Subjects with typical GERD symptoms: predominant heartburn/regurgitation

- Naive patients or off PPI treatment in the last 2 months

Exclusion Criteria:

- Inability to read and understand PRO instructions

- Patient not suitable to be treated following the AEG guidelines

- Concomitant treatment with NSAID, antiplatelet drugs

- Previous PPI failure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Research Site A Coruna La Coruna
Spain Research Site Alzira Valencia
Spain Research Site Badajoz
Spain Research Site Baracaldo Vizcaya
Spain Research Site Barcelona
Spain Research Site Bilbao Vizcaya
Spain Research Site Cabra Cordoba
Spain Research Site Cadiz
Spain Research Site Cordoba
Spain Research Site Huelva
Spain Research Site Huesca
Spain Research Site Jerez de La Frontera Cadiz
Spain Research Site La Cuesta de Arguijon Tenerife
Spain Research Site Madrid
Spain Research Site Malaga
Spain Research Site Marbella Malaga
Spain Research Site Murcia
Spain Research Site Oviedo Asturias
Spain Research Site Palma de Mallorca Baleares
Spain Research Site Sabadell Barcelona
Spain Research Site San Sebastian Guipuzcoa
Spain Research Site Santiago de Compostela La Coru?a
Spain Research Site Sevilla
Spain Research Site Tarragona
Spain Research Site Valencia
Spain Research Site Verin Orense
Spain Research Site Vigo Pontevedra
Spain Research Site Viladecans Barcelona
Spain Research Site Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptomatic outcome of GERD management following new guideline End of study visit 4-8w No
Secondary To evaluate the frequency and type of extraesophageal and dyspeptic symptoms and their impact on the clinical outcome End of study 4-8w No
Secondary To evaluate the impact of GERD symptoms in HRQoL End of study 4-8w No
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