Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00612027

Purpose

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.

Condition
Gastrointestinal Diseases

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. ]

Secondary Outcome Measures:

evaluation of a diagnosis tool [ Time Frame: evaluation of the predictive value of a two items questionnaire on acid associated symptoms ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	29586
Study Start Date:	January 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

general practitioners and internists

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612027

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:

Kai Richter, MD

Medical Department AstraZeneca Germany

More Information

No publications provided

Responsible Party:	AstraZeneca Germany ( Dr Kai Richter )
Study ID Numbers:	1312004011, German PMS trial no.9
Study First Received:	January 29, 2008
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00612027 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

gastrointestinal disorder
acid associated gastrointestinal symptoms.
esomeprazole therapy in patients with gastrointestinal disorders
patients with acid associated gastrointestinal symptoms

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 05, 2009