Gastrointestinal DiseasesNCT00612404
Symptoms and Endoscopic Results in Consideration of Pretreatment
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
- 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.
- Conditions
- Gastrointestinal Diseases
- 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 group | Role | What they receive |
|---|---|---|
| 1 | patients with gastrointestinal disorders who need an endoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted11 Feb 2008 (estimated)
- Study startSep 2005
- Primary completionDec 2005
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
- 16,255 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
- 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