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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00697008
First received: June 4, 2008
Last updated: February 9, 2009
Last verified: February 2009

June 4, 2008
February 9, 2009
December 2007
January 2009   (final data collection date for primary outcome measure)
Symptomatic outcome of GERD management following new guideline [ Time Frame: End of study visit 4-8w ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00697008 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with typical GERD symptoms consulting in specialized care setting and are managed following the new local GERD guidelines

GERD
Not Provided
GERD patients
Patients with typical GERD symptoms
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
Not Provided
January 2009   (final data collection date for primary outcome measure)

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
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00697008
NIS-GES-DUM-2007/3
No
Mercedes Muñoz, PhD, Local MC GI Therapeutic Area Manager, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Chair: Javier Zapardiel, MD AZ SPAIN
AstraZeneca
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP