GERDRANGENCT00634023
Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With GERD
An observational study of GERD, run by AstraZeneca at 15 sites in Canada.
Trial summary
This is a cross-sectional study of symptom burden and clinical management. A subset of patients who have attended the Primary Care (PC) office with reflux symptoms during a retrospective period of 4 months (Index Visit) are invited to complete health survey questionnaires and partake in a subject-physician/study nurse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- How many people
- 500 participants
- Where
- 15 sitesCanada
- Study dates
- Jan 2008to May 2008
- 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: Subjects attending PC offices with reflux symptoms. Subjects must not have participated in any other clinical study in the time window between the Index Visit and Visit 1.
Who may be able to join
- Provision of informed consent
- Ability to complete PRO instruments (non-applicable to "non-attendees")
- Subject with GERD symptom(s). At least presence of troublesome heartburn and/or regurgitation even if not specifically recorded at the Index Visit.
- At least one visit during the Retrospective Visit Period (-6 to -2 months prior to study start).
- In the reasons for the Index Visit section of the medical record mention of acid regurgitation and/or heartburn symptom(s) or GERD diagnosis or GERD complications has to be explicit or a treatment decision (prescription) in a previously diagnosed subject although no mention of symptoms is made.
Who cannot join
- Prophylactic PPI use to reduce the risk of ulcers in subjects being treated with NSAIDs
- PPI treatment to heal an ulcer induced by NSAID treatment
- PPI treatment for H-pylori eradication
- Participation in any other clinical study in the time window between the Index Visit and Visit 1
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Research Site
Cornwall, Ontario
Research Site
Edmonton, Alberta
Research Site
Exeter, Ontario
Research Site
Hamilton, Ontario
Research Site
Kanata, Ontario
Research Site
London, Ontario
Research Site
Nepean, Ontario
Research Site
Newmarket, Ontario
Research Site
North Bay, Ontario
Research Site
North Vancouver, British Columbia
Research Site
Ottawa, Ontario
Research Site
Spruce Grove, Alberta
Research Site
St. Catharines, Ontario
Research Site
Windsor, Nova Scotia
Research Site
Woodstock, Ontario
About this study
Official title: A Cross-Sectional, Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With Gastroesophageal Reflux Disease (GERD) RANGE: Retrospective ANalysis of GErd
This is a cross-sectional study of symptom burden and clinical management. A subset of patients who have attended the Primary Care (PC) office with reflux symptoms during a retrospective period of 4 months (Index Visit) are invited to complete health survey questionnaires and partake in a subject-physician/study nurse interview (Visit 1), in order to assess the type, intensity and frequency of GERD symptoms at both visits and describe the treatment provided. Additionally, the impact of GERD on subjects' life, productivity and willingness to pay for GERD symptom relief will be explored. This design will give a "real-life" clinical practice picture in a representative population of PC doctors and subjects.
- Conditions
- GERD
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the impact of reflux symptoms on subjects' daily life
Measured: Assessed by means of the patient reported outcomes (PROs)
Secondary outcomes (1)
To describe the impact of reflux symptoms on work productivity
Measured: Assessed by means of the patient reported outcomes (PROs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionMay 2008
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
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634023
- Sponsor's protocol ID
- D9612L00113
- Acronym
- RANGE
- Status last verified
- Mar 2009
- First submitted
- 5 Mar 2008
- Last updated
- 11 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional, Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With Gastroesophageal Reflux Disease (GERD) RANGE: Retrospective ANalysis of GErd
- ClinicalTrials.gov ID
- NCT00634023
- Acronym / sponsor ID
- RANGE / D9612L00113
- Conditions
- GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Mar 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.
This is a cross-sectional study of symptom burden and clinical management. A subset of patients who have attended the Primary Care (PC) office with reflux symptoms during a retrospective period of 4 months (Index Visit) are invited to complete health survey questionnaires and partake in a subject-physician/study nurse interview (Visit 1), in order to assess the type, intensity and frequency of GERD symptoms at both visits and describe the treatment provided. Additionally, the impact of GERD on subjects' life, productivity and willingness to pay for GERD symptom relief will be explored. This design will give a "real-life" clinical practice picture in a representative population of PC doctors and subjects.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects attending PC offices with reflux symptoms. Subjects must not have participated in any other clinical study in the time window between the Index Visit and Visit 1.
Key inclusion criteria (5 listed)
- Provision of informed consent
- Ability to complete PRO instruments (non-applicable to "non-attendees")
- Subject with GERD symptom(s). At least presence of troublesome heartburn and/or regurgitation even if not specifically recorded at the Index Visit.
- At least one visit during the Retrospective Visit Period (-6 to -2 months prior to study start).
- In the reasons for the Index Visit section of the medical record mention of acid regurgitation and/or heartburn symptom(s) or GERD diagnosis or GERD complications has to be explicit or a treatment decision (prescription) in a previously diagnosed subject although no mention of symptoms is made.
Key exclusion criteria (4 listed)
- Prophylactic PPI use to reduce the risk of ulcers in subjects being treated with NSAIDs
- PPI treatment to heal an ulcer induced by NSAID treatment
- PPI treatment for H-pylori eradication
- Participation in any other clinical study in the time window between the Index Visit and Visit 1
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 describe the impact of reflux symptoms on subjects' daily life
Time frame: Assessed by means of the patient reported outcomes (PROs)
1 secondary outcome
To describe the impact of reflux symptoms on work productivity
Time frame: Assessed by means of the patient reported outcomes (PROs)
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 Mar 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites 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 15 sites in Canada.
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 5 inclusion and 4 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 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. 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.
What does the primary outcome measure?
To describe the impact of reflux symptoms on subjects' daily life (time frame: Assessed by means of the patient reported outcomes (PROs)). 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 Mar 2009.