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Gastrointestinal DiseasesNCT00612404

Symptoms and Endoscopic Results in Consideration of Pretreatment

An observational study of Gastrointestinal Diseases, run by AstraZeneca.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Gastrointestinal Diseases
How many people
16,255 participants
Where
No sites listed yet
Study dates
Sep 2005to Dec 2005
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: gastroenterologists; specialists

Who may be able to join

  • patients with gastrointestinal disorders who need an endoscopy.

Who cannot join

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

About this study

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.

Keywords
gastrointestinal disorder, endoscopy, patient with gastrointestinal disorders for whom an endoscopy is performed and who is treated with esomeprazole afterwards.
Medical subject headings
Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00612404
Study groupRoleWhat they receive
1patients with gastrointestinal disorders who need an endoscopy.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2008 (estimated)
  2. Study startSep 2005
  3. Primary completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
16,255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00612404
Sponsor's protocol ID
1312004008
Status last verified
Jan 2008
First submitted
28 Jan 2008
Last updated
11 Feb 2008
Results posted
No
Data monitoring committee
No

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