- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00612404
Symptoms and Endoscopic Results in Consideration of Pretreatment
February 8, 2008 updated by: AstraZeneca
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
16255
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
gastroenterologists; specialists
Description
Inclusion Criteria:
- patients with gastrointestinal disorders who need an endoscopy.
Exclusion Criteria:
- limitiations; possible risks; warnings; contraindications mentioned in the SPC.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
1
patients with gastrointestinal disorders who need an endoscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
to gain insight into the currently used treatment strategies with esomeprazole depending on endoscopic findings.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kai Richter, MD, Medical Department AstraZeneca Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
January 28, 2008
First Submitted That Met QC Criteria
February 8, 2008
First Posted (Estimate)
February 11, 2008
Study Record Updates
Last Update Posted (Estimate)
February 11, 2008
Last Update Submitted That Met QC Criteria
February 8, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1312004008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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