NCT00612404

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,255

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
Last Updated

February 11, 2008

Status Verified

January 1, 2008

Enrollment Period

3 months

First QC Date

January 28, 2008

Last Update Submit

February 8, 2008

Conditions

Gastrointestinal Diseases

Keywords

gastrointestinal disorderendoscopypatient with gastrointestinal disorders for whom an endoscopy is performed and who is treated with esomeprazole afterwards.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

Study Arms (1)

1

patients with gastrointestinal disorders who need an endoscopy.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

gastroenterologists; specialists

You may qualify if:

  • patients with gastrointestinal disorders who need an endoscopy.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Kai Richter, MD

    Medical Department AstraZeneca Germany

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 11, 2008

Study Start

September 1, 2005

Primary Completion

December 1, 2005

Last Updated

February 11, 2008

Record last verified: 2008-01