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NCT00612027 Clinical Trial

Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions

Gastrointestinal Diseases Clinical Trial

Official title:
Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00612027
Other study ID # 1312004011
Secondary ID German PMS trial
Status Completed
Phase N/A
First received January 29, 2008
Last updated February 8, 2008
Start date January 2006

Study information
Verified date January 2008
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 29586
Est. completion date
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary 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 evaluation of a diagnosis tool evaluation of the predictive value of a two items questionnaire on acid associated symptoms
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