Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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

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
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, see Learn About Clinical Studies.

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: Dr Kai Richter, AstraZeneca Germany
ClinicalTrials.gov Identifier: NCT00612027     History of Changes
Other Study ID Numbers: 1312004011, German PMS trial no.9
Study First Received: January 29, 2008
Last Updated: February 8, 2008
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 27, 2014