Asociación Española de Gastroenterologia (Spanish Gastroenterology Association) Gastroesophageal Reflux Disease Guideline - Prospective Study
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00697008
First received: June 4, 2008
Last updated: February 9, 2009
Last verified: February 2009
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Purpose
To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP Guideline.
| Condition |
|---|
|
GERD |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Symptomatic Assessment and Therapeutic Outcomes in Typical GERD Patients Following a New CP Guideline in the Clinical Practice |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Symptomatic outcome of GERD management following new guideline [ Time Frame: End of study visit 4-8w ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- To evaluate the impact of GERD symptoms in HRQoL [ Time Frame: End of study 4-8w ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2007 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
GERD patients
Patients with typical GERD symptoms
|
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697008
Locations
| Spain | |
| Research Site | |
| Oviedo, Asturias, Spain | |
| Research Site | |
| Palma de Mallorca, Baleares, Spain | |
| Research Site | |
| Sabadell, Barcelona, Spain | |
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| Viladecans, Barcelona, Spain | |
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| Jerez de La Frontera, Cadiz, Spain | |
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| Cabra, Cordoba, Spain | |
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| San Sebastian, Guipuzcoa, Spain | |
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| A Coruna, La Coruna, Spain | |
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| Santiago de Compostela, La Coru�a, Spain | |
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| Marbella, Malaga, Spain | |
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| Verin, Orense, Spain | |
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| Vigo, Pontevedra, Spain | |
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| La Cuesta de Arguijon, Tenerife, Spain | |
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| Alzira, Valencia, Spain | |
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| Baracaldo, Vizcaya, Spain | |
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| Bilbao, Vizcaya, Spain | |
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| Badajoz, Spain | |
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| Barcelona, Spain | |
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| Cadiz, Spain | |
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| Cordoba, Spain | |
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| Huelva, Spain | |
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| Huesca, Spain | |
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| Madrid, Spain | |
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| Malaga, Spain | |
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| Murcia, Spain | |
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| Sevilla, Spain | |
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| Tarragona, Spain | |
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| Valencia, Spain | |
| Research Site | |
| Zaragoza, Spain | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Chair: | Javier Zapardiel, MD | AZ SPAIN |
More Information
No publications provided
| Responsible Party: | Mercedes Muñoz, PhD, Local MC GI Therapeutic Area Manager, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00697008 History of Changes |
| Other Study ID Numbers: | NIS-GES-DUM-2007/3 |
| Study First Received: | June 4, 2008 |
| Last Updated: | February 9, 2009 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by AstraZeneca:
|
GERD CLINICAL GUIDELINE Symptoms clinical outcome |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013