Clinical trial NCT00697008: Asociación Española de Gastroenterologia (Spanish Gastroenterology Association) Gastroesophageal Reflux Disease Guideline - Prospective Study
Official title: Symptomatic Assessment and Therapeutic Outcomes in Typical GERD Patients Following a New CP Guideline in the Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GERD
Keywords: GERD
CLINICAL GUIDELINE
Symptoms
clinical outcome
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 300
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with typical GERD symptoms consulting in specialized care setting and are managed following the new local GERD guidelines

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


Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic outcome of GERD management following new guideline
timeFrame: End of study visit 4-8w
Secondary outcomes:
measure: To evaluate the frequency and type of extraesophageal and dyspeptic symptoms and their impact on the clinical outcome
timeFrame: End of study 4-8w
measure: To evaluate the impact of GERD symptoms in HRQoL
timeFrame: End of study 4-8w
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: Sabadell
country: Spain
facility: Research Site
state: Barcelona
city: Viladecans
country: Spain
facility: Research Site
state: Barcelona
city: Jerez de La Frontera
country: Spain
facility: Research Site
state: Cadiz
city: Cabra
country: Spain
facility: Research Site
state: Cordoba
city: San Sebastian
country: Spain
facility: Research Site
state: Guipuzcoa
city: A Coruna
country: Spain
facility: Research Site
state: La Coruna
city: Santiago de Compostela
country: Spain
facility: Research Site
state: La Coru�a
city: Marbella
country: Spain
facility: Research Site
state: Malaga
city: Verin
country: Spain
facility: Research Site
state: Orense
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: La Cuesta de Arguijon
country: Spain
facility: Research Site
state: Tenerife
city: Alzira
country: Spain
facility: Research Site
state: Valencia
city: Baracaldo
country: Spain
facility: Research Site
state: Vizcaya
city: Bilbao
country: Spain
facility: Research Site
state: Vizcaya
city: Badajoz
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cadiz
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Huelva
country: Spain
facility: Research Site
city: Huesca
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
affiliation: AZ SPAIN
name: Javier Zapardiel, MD
role: STUDY_CHAIR
References: