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.
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.
- Conditions
- Gastrointestinal Diseases
- 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 group | Role | What they receive |
|---|---|---|
| 1 | patients 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.
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)
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.
- First posted11 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kai Richter, MD, Study chair, Medical Department AstraZeneca Germany
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