GERDNCT00884247
Structured Treatment of Gastroesophageal Reflux in a Company Health Care Setting, -Effect on Quality of Life, Symptoms and Productivity
An observational study of GERD, run by AstraZeneca at 1 site in Sweden.
Trial summary
The study aims to evaluate if a GERD treatment programme, in accordance with current regional recommendations, in a company health care setting, has an impact on health related quality of life (HRQoL), symptoms, and productivity in GERD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2009to Jun 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Company health care setting
Who may be able to join
- Female and/or male aged > 18 years
- Diagnosis of GERD confirmed
- Prescription of GERD treatment or already receiving GERD treatment
Who cannot join
- Any symptom suggesting a need for further investigation
- Previous participation in the present study
- Current participation in a clinical study or participation in a clinical study during the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non Interventional Study to Evaluate the Effects on Quality of Life, Symptoms and Productivity in Patients With Gastroesophageal Reflux Disease (GERD) After 6 Weeks Structured Treatment in a Company Health Care Setting
The study aims to evaluate if a GERD treatment programme, in accordance with current regional recommendations, in a company health care setting, has an impact on health related quality of life (HRQoL), symptoms, and productivity in GERD patients.
- Conditions
- GERD
- Keywords
- GERD, Quality of life, Structured treatment
- 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 posted20 Apr 2009 (estimated)
- Study startApr 2009
- Study completionJun 2009
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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Svante Sjöstedt, MD, PhD, Study director, AstraZeneca SwedenDan Regberg, MD, Principal investigator, AstraZeneca Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884247
- Sponsor's protocol ID
- NIS-GSE-DUM-2009/1
- Status last verified
- Dec 2010
- First submitted
- 17 Apr 2009
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non Interventional Study to Evaluate the Effects on Quality of Life, Symptoms and Productivity in Patients With Gastroesophageal Reflux Disease (GERD) After 6 Weeks Structured Treatment in a Company Health Care Setting
- ClinicalTrials.gov ID
- NCT00884247
- Acronym / sponsor ID
- NIS-GSE-DUM-2009/1
- Conditions
- GERD
- Keywords
- GERD, Quality of life, Structured treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Apr 2009 (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.
The study aims to evaluate if a GERD treatment programme, in accordance with current regional recommendations, in a company health care setting, has an impact on health related quality of life (HRQoL), symptoms, and productivity in GERD patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Company health care setting
Key inclusion criteria (3 listed)
- Female and/or male aged > 18 years
- Diagnosis of GERD confirmed
- Prescription of GERD treatment or already receiving GERD treatment
Key exclusion criteria (3 listed)
- Any symptom suggesting a need for further investigation
- Previous participation in the present study
- Current participation in a clinical study or participation in a clinical study during the last 30 days
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 7 Dec 2010.
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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.
Svante Sjöstedt, MD, PhD study director
AstraZeneca Sweden
Dan Regberg, MD principal investigator
AstraZeneca Sweden
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 Sweden.
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 3 inclusion and 3 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 7 Dec 2010. 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 Sweden. 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 7 Dec 2010.