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Symptoms and Endoscopic Results in Consideration of Pretreatment

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00612404
First received: January 28, 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. gastroenterologists) are asked to document relevant data in patients with gastrointestinal disorders.


Condition
Gastrointestinal Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symptoms and Endoscopic Results in Consideration of Pretreatment

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • to gain insight into the relationship between subjective gastrointestinal symptoms and findings of a laryngopharyngeal-esophagogastric endoscopy with respect to the medicinal pre-therapy;

Secondary Outcome Measures:
  • to gain insight into the currently used treatment strategies with esomeprazole depending on endoscopic findings.

Enrollment: 16255
Study Start Date: September 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients with gastrointestinal disorders who need an endoscopy.

  Eligibility

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

gastroenterologists; specialists

Criteria

Inclusion Criteria:

  • patients with gastrointestinal disorders who need an endoscopy.

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: NCT00612404

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: NCT00612404     History of Changes
Other Study ID Numbers: 1312004008
Study First Received: January 28, 2008
Last Updated: February 8, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
gastrointestinal disorder
endoscopy
patient with gastrointestinal disorders for whom an endoscopy is performed and who is treated with esomeprazole afterwards.

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014