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

Completed

• Conditions: GERD

• Registration Number: NCT00697008
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Primary Completion: 2009-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-09
• Last Update Posted: 2009-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic outcome of GERD management following new guideline	End of study visit 4-8w

Secondary Outcome Measures

Name	Time	Method
To evaluate the frequency and type of extraesophageal and dyspeptic symptoms and their impact on the clinical outcome	End of study 4-8w
To evaluate the impact of GERD symptoms in HRQoL	End of study 4-8w

Trial Locations

Locations (1)

Research Site; 🇪🇸 Zaragoza, Spain