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

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

Completed

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Badajoz, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Symptomatic outcome of GERD management following new guideline

Time frame: End of study visit 4-8w

Secondary outcomes

To evaluate the frequency and type of extraesophageal and dyspeptic symptoms and their impact on the clinical outcome

Time frame: End of study 4-8w
To evaluate the impact of GERD symptoms in HRQoL

Time frame: End of study 4-8w

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: Prospect

Important dates

Study start: 2007
Primary completion: 2009
First posted: Jun 13, 2008
Registry last updated: Feb 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed