GERDNCT00567619
LIFE NIS, GERD-Patients - Evaluation of Burden of Disease Determined by GERD Impact Scale (GIS)
An observational study of GERD, run by AstraZeneca at 1 site in Austria.
Trial summary
Evaluate burden of disease in Patients with newly occurred upper GI symptoms related to GERD (symptom frequency \& severity, QoL, lifestyle modifications, self-medication) - baseline data according to GERD impact scale presenting to specialists, especially internists Evaluate effect of treatment with a acid… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- GERD
- How many people
- 900 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2007to not given
- 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
Who may be able to join
- Patients with newly occured upper GI symptoms related to GERD
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate burden of disease in Patients with newly occurred upper GI symptoms related to GERD (symptom frequency \& severity, QoL, lifestyle modifications, self-medication) - baseline data according to GERD impact scale presenting to specialists, especially internists
- Evaluate effect of treatment with a acid suppressive therapy on these parameters: looking for improvement of symptom burden and quality of life according to the GERD impact sca
- Conditions
- GERD
- Keywords
- GERD, NIS
- Medical subject headings
- Gastroesophageal Reflux
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- 900 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Not required for Study, Study chair, Not required for this study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567619
- Sponsor's protocol ID
- NIS-GAT-NEX-2007/1
- Status last verified
- Feb 2008
- First submitted
- 20 Sep 2007
- Last updated
- 18 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFE NIS, GERD-Patients - Evaluation of Burden of Disease Determined by GERD Impact Scale (GIS)
- ClinicalTrials.gov ID
- NCT00567619
- Acronym / sponsor ID
- NIS-GAT-NEX-2007/1
- Conditions
- GERD
- Keywords
- GERD, NIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- First posted
- 5 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.
Evaluate burden of disease in Patients with newly occurred upper GI symptoms related to GERD (symptom frequency \& severity, QoL, lifestyle modifications, self-medication) - baseline data according to GERD impact scale presenting to specialists, especially internists
- Evaluate effect of treatment with a acid suppressive therapy on these parameters: looking for improvement of symptom burden and quality of life according to the GERD impact sca
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with newly occured upper GI symptoms related to GERD
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 18 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.
Not required for Study study chair
Not required for this study
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by AstraZeneca at 1 site in Austria.
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 0 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 18 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 18 Feb 2008.