Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions
Completed
- Conditions
- Gastrointestinal Diseases
- Registration Number
- NCT00612027
- Lead Sponsor
- AstraZeneca
- Brief Summary
Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. general practitioners and internists) are asked to document relevant data related to esomeprazole therapy in patients with gastrointestinal disorders. Patients with acid associated gastrointestinal symptoms can be included.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29586
Inclusion Criteria
- patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.
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Exclusion Criteria
- limitiations; possible risks; warnings; contraindications mentioned in the SPC.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists proportion of treated subjects without any specific acid associated symptoms at the end of the study; change in intensity of specific acid associated symptoms; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE.
- Secondary Outcome Measures
Name Time Method evaluation of a diagnosis tool evaluation of the predictive value of a two items questionnaire on acid associated symptoms