Text Size

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
History of Changes
  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:

U.S. FDA Resources

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
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:
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013