NCT00612027

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. general practitioners and internists) are asked to document relevant data related to esomeprazole therapy in patients with gastrointestinal disorders. Patients with acid associated gastrointestinal symptoms can be included.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
29,586

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

January 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
13 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

2 months

First QC Date

January 29, 2008

Last Update Submit

February 8, 2008

Conditions

Gastrointestinal Diseases

Keywords

gastrointestinal disorderacid associated gastrointestinal symptoms.esomeprazole therapy in patients with gastrointestinal disorderspatients with acid associated gastrointestinal symptoms

Outcome Measures

Primary Outcomes (1)

  • efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists

    proportion of treated subjects without any specific acid associated symptoms at the end of the study; change in intensity of specific acid associated symptoms; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE.

Secondary Outcomes (1)

  • evaluation of a diagnosis tool

    evaluation of the predictive value of a two items questionnaire on acid associated symptoms

Study Arms (1)

1

patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.

Eligibility Criteria

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

general practitioners and internists

You may qualify if:

  • patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.

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 29, 2008

First Posted

February 11, 2008

Study Start

January 1, 2006

Primary Completion

March 1, 2006

Last Updated

February 11, 2008

Record last verified: 2008-01