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
- 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: 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
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
- Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions
- ClinicalTrials.gov ID
- NCT00612027
- Acronym / sponsor ID
- 1312004011
- Conditions
- Gastrointestinal Diseases
- Keywords
- gastrointestinal disorder, acid associated gastrointestinal symptoms., esomeprazole therapy in patients with gastrointestinal disorders, patients with acid associated gastrointestinal symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29,586 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Mar 2006 (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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- general practitioners and internists
Key inclusion criteria (1 listed)
- patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.
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
efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists
Time frame: 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.
1 secondary outcome
evaluation of a diagnosis tool
Time frame: evaluation of the predictive value of a two items questionnaire on acid associated symptoms
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?
efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists (time frame: 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.). 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.