Symptoms and Endoscopic Results in Consideration of Pretreatment

This study has been completed.

First Received on January 28, 2008. Last Updated on February 8, 2008 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00612404

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:

MedlinePlus related topics: Endoscopy

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 February 12, 2012