Gastroesophageal RefluxNCT00567021
German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
An observational study of Gastroesophageal Reflux, run by AstraZeneca.
Trial summary
This PMS study had the objective to evaluate under ordinary medical care conditions the efficacy and tolerability of esomeprazole in patients who where treated by general practitioners and internists. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastroesophageal Reflux
- How many people
- 67,130 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: PC and internist
Who may be able to join
- Patients with GERD, or NSAID related ulcers, who need treatment with esomeprazole.
Who cannot join
- Limitations; possible risks; warnings; contraindications mentioned in the SPC.
About this study
This PMS study had the objective to evaluate under ordinary medical care conditions the efficacy and tolerability of esomeprazole in patients who where treated by general practitioners and internists.
- Conditions
- Gastroesophageal Reflux
- Keywords
- reflux, NSAR treatment, Patients with reflux symptoms or gastrointestinal symptoms after NSAR Treatment
- Medical subject headings
- Gastroesophageal Reflux
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 GERD or NSAID-related ulcers |
What is being measured
The primary outcome is the main question the study is designed to answer.
To gain further insight into the efficacy of esomeprazole under ordinary medical care conditions in consideration of diagnosis and type of NSAID therapy (if administered).
Measured: By estimating the proportion of treated subjects without any gastrointestinal symptoms at the end of the observational period 2. by assessing the change in intensity of gastrointestinal symptoms.
Secondary outcomes (1)
To get further insight into the details of the use, dosage scheme and duration of treatment with esomeprazole in this population
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startSep 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies 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
- Time perspective
- Prospective
- Enrolment
- 67,130 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kai Richter, MD, Study director, AstraZeneca Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567021
- Sponsor's protocol ID
- 1312004007
- Other IDs
- German PMS trial no.7
- Status last verified
- Jan 2008
- First submitted
- 3 Dec 2007
- Last updated
- 29 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
- ClinicalTrials.gov ID
- NCT00567021
- Acronym / sponsor ID
- 1312004007
- Conditions
- Gastroesophageal Reflux
- Keywords
- reflux, NSAR treatment, Patients with reflux symptoms or gastrointestinal symptoms after NSAR Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67,130 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Dec 2005 (actual)
- First posted
- 4 Dec 2007 (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.
This PMS study had the objective to evaluate under ordinary medical care conditions the efficacy and tolerability of esomeprazole in patients who where treated by general practitioners and internists.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with GERD or NSAID-related ulcers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- PC and internist
Key inclusion criteria (1 listed)
- Patients with GERD, or NSAID related ulcers, who need treatment with esomeprazole.
Key exclusion criteria (1 listed)
- Limitations; 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 further insight into the efficacy of esomeprazole under ordinary medical care conditions in consideration of diagnosis and type of NSAID therapy (if administered).
Time frame: By estimating the proportion of treated subjects without any gastrointestinal symptoms at the end of the observational period 2. by assessing the change in intensity of gastrointestinal symptoms.
1 secondary outcome
To get further insight into the details of the use, dosage scheme and duration of treatment with esomeprazole in this population
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 29 Jan 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 director
AstraZeneca Medical Department
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, 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 29 Jan 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 further insight into the efficacy of esomeprazole under ordinary medical care conditions in consideration of diagnosis and type of NSAID therapy (if administered). (time frame: By estimating the proportion of treated subjects without any gastrointestinal symptoms at the end of the observational period 2. by assessing the change in intensity of gastrointestinal symptoms.). 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 29 Jan 2008; AzTrials last refreshed its copy on 6 Nov 2026.