Symptoms and Endoscopic Results in Consideration of Pretreatment - Full Text View

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

MedlinePlus related topics:

Endoscopy

Drug Information available for:

Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Symptoms and Endoscopic Results in Consideration of Pretreatment

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.

Biospecimen Retention: None Retained

Biospecimen Description:

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

Responsible Party:	AstraZeneca Germany ( Dr Kai Richter )
Study ID Numbers:	1312004008
First Received:	January 28, 2008
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00612404
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.

Study placed in the following topic categories:

Digestive System Diseases

Gastrointestinal Diseases

Omeprazole

ClinicalTrials.gov processed this record on October 23, 2008

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