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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00612027
First received: January 29, 2008
Last updated: February 8, 2008
Last verified: January 2008

January 29, 2008
February 8, 2008
January 2006
March 2006   (final data collection date for primary outcome measure)
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. ]
Same as current
Complete list of historical versions of study NCT00612027 on ClinicalTrials.gov Archive Site
evaluation of a diagnosis tool [ Time Frame: evaluation of the predictive value of a two items questionnaire on acid associated symptoms ]
Same as current
Not Provided
Not Provided
 
Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

general practitioners and internists

Gastrointestinal Diseases
Not Provided
1
patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29586
Not Provided
March 2006   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00612027
1312004011, German PMS trial no.9
No
Dr Kai Richter, AstraZeneca Germany
AstraZeneca
Not Provided
Study Chair: Kai Richter, MD Medical Department AstraZeneca Germany
AstraZeneca
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP