Gastrointestinal Diseases
Conditions
Keywords
gastrointestinal disorder, acid associated gastrointestinal symptoms., esomeprazole therapy in patients with gastrointestinal disorders, patients with acid associated gastrointestinal symptoms
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.
Exclusion criteria
* limitiations; possible risks; warnings; contraindications mentioned in the SPC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| evaluation of a diagnosis tool | evaluation of the predictive value of a two items questionnaire on acid associated symptoms |
Outcome results
None listed