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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms and Endoscopic Results in Consideration of Pretreatment
- ClinicalTrials.gov ID
- NCT00612404
- Acronym / sponsor ID
- 1312004008
- Conditions
- Gastrointestinal Diseases
- Keywords
- gastrointestinal disorder, endoscopy, patient with gastrointestinal disorders for whom an endoscopy is performed and who is treated with esomeprazole afterwards.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,255 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Dec 2005 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with gastrointestinal disorders who need an endoscopy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- gastroenterologists; specialists
Key inclusion criteria (1 listed)
- patients with gastrointestinal disorders who need an endoscopy.
Key exclusion criteria (1 listed)
- limitiations; possible risks; warnings; contraindications mentioned in the SPC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to gain insight into the relationship between subjective gastrointestinal symptoms and findings of a laryngopharyngeal-esophagogastric endoscopy with respect to the medicinal pre-therapy;
1 secondary outcome
to gain insight into the currently used treatment strategies with esomeprazole depending on endoscopic findings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Richter, MD study chair
Medical Department AstraZeneca Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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;. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2008.