Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions|
- efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists [ Time Frame: 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. ]
- evaluation of a diagnosis tool [ Time Frame: evaluation of the predictive value of a two items questionnaire on acid associated symptoms ]
|Study Start Date:||January 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612027
|Study Chair:||Kai Richter, MD||Medical Department AstraZeneca Germany|