Symptoms and Endoscopic Results in Consideration of Pretreatment

Gastrointestinal Diseases Clinical Trial

Official title:

Symptoms and Endoscopic Results in Consideration of Pretreatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612404
• Other study ID #: 1312004008
• Status: Completed
• Phase: N/A
• First received: January 28, 2008
• Last updated: February 8, 2008
• Start date: September 2005

Study information

• Verified date: January 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16255
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with gastrointestinal disorders who need an endoscopy.

Exclusion Criteria:

• limitiations; possible risks; warnings; contraindications mentioned in the SPC.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to gain insight into the currently used treatment strategies with esomeprazole depending on endoscopic findings.