We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00612027
First Posted: February 11, 2008
Last Update Posted: February 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612027


Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Kai Richter, MD Medical Department AstraZeneca Germany
  More Information

Responsible Party: Dr Kai Richter, AstraZeneca Germany
ClinicalTrials.gov Identifier: NCT00612027     History of Changes
Other Study ID Numbers: 1312004011
German PMS trial no.9
First Submitted: January 29, 2008
First Posted: February 11, 2008
Last Update Posted: February 11, 2008
Last Verified: January 2008

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:
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action