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Gastrointestinal DiseasesNCT00612027

Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions

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
29,586 participants
Where
No sites listed yet
Study dates
Jan 2006to Mar 2006
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: general practitioners and internists

Who may be able to join

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

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. 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.

Keywords
gastrointestinal disorder, acid associated gastrointestinal symptoms., esomeprazole therapy in patients with gastrointestinal disorders, patients with acid associated gastrointestinal symptoms
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 NCT00612027
Study groupRoleWhat they receive
1patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.

What is being measured

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

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

    Measured: 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)
  1. evaluation of a diagnosis tool

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

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 startJan 2006
  3. Primary completionMar 2006

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
29,586 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00612027
Sponsor's protocol ID
1312004011
Other IDs
German PMS trial no.9
Status last verified
Jan 2008
First submitted
29 Jan 2008
Last updated
11 Feb 2008
Results posted
No
Data monitoring committee
No

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