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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00697008

Acronym

Prospect

Enrollment

300

Registered

2008-06-13

Start date

2007-12-31

Completion date

Unknown

Last updated

2009-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Keywords

GERD, CLINICAL GUIDELINE, Symptoms, clinical outcome

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Spain

Outcome results