RefluxNCT00842387
Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)
An observational study of Reflux and Heartburn, run by AstraZeneca at 66 sites in 5 countries.
Trial summary
The aim of this project is to compare the GERD clinical outcomes in patients where a structured pathway using the GerdQ questionnaire is implemented compared with the clinical outcomes of those treated without this implementation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reflux, Heartburn, Regurgitation
- How many people
- 2,370 participants
- Where
- 66 sitesin 5 countries
- Study dates
- Jan 2009to Dec 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: Patients with symptoms suggestive of GERD.
Who may be able to join
- Patients presenting with symptoms suggestive of GERD (heartburn or regurgitation as prevailing symptoms) of any severity
- Patient able to understand and complete the questionnaires
Who cannot join
- Alarm symptoms (Dysphagia/odynophagia, anorexia, anaemia, unintentional weight loss, abdominal mass, upper GI bleeding)
- If the patient is participating in any clinical trial, he/she cannot take part on this study
- Any condition that, in the investigator's opinion, makes the patient's participation in the study difficult
Trial locations and contacts
66 sites in 5 countries.
66 sites in 5 countries
Austria30 sites
Research Site
Amstetten
Research Site
Baden
Research Site
Bludenz
Research Site
Bregenz
Research Site
Feldbach
Research Site
Gmunden
Research Site
Graz
Research Site
Groß-Gerungs
Research Site
Innsbruck
Research Site
Kitzbühel
Research Site
Klagenfurt
Research Site
Krems
Research Site
Kufstein
Research Site
Leibnitz, Styria
Research Site
Leoben
Research Site
Linz
Research Site
Mattersburg
Research Site
Mistelbach
Research Site
Mürzzuschlag
Research Site
Neunkirchen
Research Site
Neusiedl
Research Site
Perg
Research Site
Sankt Veit im Pongau
Research Site
Schwaz
Research Site
Steyr
Research Site
Villach
Research Site
Vöcklabruck
Research Site
Völkermarkt
Research Site
Wels
Research Site
Zell
Sweden22 sites
Research Site
Arlöv
Research Site
Dalby
Research Site
Falköping
Research Site
Färsta
Research Site
Gothenburg
Research Site
Helsingborg
Research Site
Karlshamn
Research Site
Kristianstad
Research Site
Kungsängen
Research Site
Luleå
Research Site
Lund
Research Site
Malmö
Research Site
Munkedal
Research Site
Nordstan(Goteborg)
Research Site
Partille
Research Site
Piteå
Research Site
Skanör
Research Site
Södertälje
Research Site
Solna
Research Site
Stockholm
Research Site
Trollhättan
Research Site
Vännäs
Norway12 sites
Research Site
Ålesund
Research Site
Arendal
Research Site
Bergen
Research Site
Bodø
Research Site
Haugesund
Research Site
Kristiansund
Research Site
Levanger
Research Site
Molde
Research Site
Mosjøen
Research Site
Orkdal
Research Site
Oslo
Research Site
Tynset
About this study
The aim of this project is to compare the GERD clinical outcomes in patients where a structured pathway using the GerdQ questionnaire is implemented compared with the clinical outcomes of those treated without this implementation.
This is a European project with 5 participating countries (Austria, Italy, Norway, Spain and Sweden). Due to different characteristics regarding the actual management of this disease in the 5 countries, each country had the flexibility to introduce design differences and changes in the study protocol.
Read the detailed description
In Norway, it is developed as a clinical trial where a new structured pathway in the diagnosis and treatment of GERD is compared to the ordinary clinical pathway consisting of the endoscopic/pH-metry approach in patients referred from primary care to GI specialists.
In Italy, it is a PCP-level, cluster randomized, controlled trial comparing a structured clinical pathway versus usual care in patients with GERD. The implementation consists of training sessions on the clinical pathway with the selected PCPs (Implementation Group).
In Sweden, it is a cluster-randomised interventional study performed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway in patients identified as having GERD. The participating PCCs will be randomised (1:1) to implement the structured clinical pathway or handling the patients according to local clinical routines.
In Austria and Spain, it is a cluster-randomized study to be developed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway on GERD patients . The evaluation study will take place subsequent to a prior implementation of a clinical pathway. The implementation consists of a detailed explanation by training-materials about the clinical pathway in a selected randomized pool of PCCs. The implementation that will be evaluated is outside of the study procedures; it is the physician's decision whether to apply it or not.
- Conditions
- Reflux, Heartburn, Regurgitation, Esophagitis
- Keywords
- gastroesophageal reflux disease, reflux, heartburn, regurgitation, acid control, PPI, antiacid, primary care, esophagitis
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Esophagitis
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 symptoms suggestive of GERD, managed according to a new structured and implemented pathway | |
| 2 | Patients with symptoms suggestive of GERD, managed according to usual clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of symptoms based on results of GerdQ, need of treatment change and % of patients requiring referral to a specialist (Austria and Italy).
Measured: up to 8 weeks
Treatment response and symptomatic control (Norway)
Measured: up to 8 weeks
Symptom relief and patient satisfaction with treatment (Spain)
Measured: up to 8 weeks
Symptom relief measured by RDQ (Sweden)
Measured: 5 months +/- 4 weeks
Secondary outcomes (3)
Use and consumption of healthcare resources (all countries). Physicians adherence to the clinical pathway (Austria, Spain) and intrinsic characteristics of the physicians/PCC that may affect this adherence (Austria)
Measured: Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks
Percentage of patients referred to specialists (Spain). Health status based on EQ-5D measure (Norway, Sweden). Work productivity based on the WPAI-GERD questionnaire (Norway, Sweden)
Measured: Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks
Sweden: Persisting symptoms according to GerdQ, Treatment changes, Reason(s) for the patient consultation at visit 1. To explore other GERD related symptoms, To describe patients' experience of treatment/care given during the study.
Measured: 5 months +/- 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJan 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mónica Tafalla, MD, Study director, Medical DepartmentAstraZeneca Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842387
- Sponsor's protocol ID
- NIS-GEU-DUM-2008/1
- Status last verified
- Dec 2009
- First submitted
- 11 Feb 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bergquist H, Agreus L, Tillander L, Johnsson F, Sorngard H, Sjostedt S, Hellstrom PM. Structured diagnostic and treatment approach versus the usual primary care approach in patients with gastroesophageal reflux disease: a cluster-randomized multicenter study. J Clin Gastroenterol. 2013 Aug;47(7):e65-73. doi: 10.1097/MCG.0b013e31827d7782.
PubMed 23426452Jonasson C, Moum B, Bang C, Andersen KR, Hatlebakk JG. Randomised clinical trial: a comparison between a GerdQ-based algorithm and an endoscopy-based approach for the diagnosis and initial treatment of GERD. Aliment Pharmacol Ther. 2012 Jun;35(11):1290-300. doi: 10.1111/j.1365-2036.2012.05092.x. Epub 2012 Apr 18.
PubMed 22510027
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00842387
- Acronym / sponsor ID
- NIS-GEU-DUM-2008/1
- Conditions
- Reflux, Heartburn, Regurgitation, Esophagitis
- Keywords
- gastroesophageal reflux disease, reflux, heartburn, regurgitation, acid control, PPI, antiacid, primary care, esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,370 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Feb 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 aim of this project is to compare the GERD clinical outcomes in patients where a structured pathway using the GerdQ questionnaire is implemented compared with the clinical outcomes of those treated without this implementation.
This is a European project with 5 participating countries (Austria, Italy, Norway, Spain and Sweden). Due to different characteristics regarding the actual management of this disease in the 5 countries, each country had the flexibility to introduce design differences and changes in the study protocol.
Detailed description
In Norway, it is developed as a clinical trial where a new structured pathway in the diagnosis and treatment of GERD is compared to the ordinary clinical pathway consisting of the endoscopic/pH-metry approach in patients referred from primary care to GI specialists.
In Italy, it is a PCP-level, cluster randomized, controlled trial comparing a structured clinical pathway versus usual care in patients with GERD. The implementation consists of training sessions on the clinical pathway with the selected PCPs (Implementation Group).
In Sweden, it is a cluster-randomised interventional study performed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway in patients identified as having GERD. The participating PCCs will be randomised (1:1) to implement the structured clinical pathway or handling the patients according to local clinical routines.
In Austria and Spain, it is a cluster-randomized study to be developed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway on GERD patients . The evaluation study will take place subsequent to a prior implementation of a clinical pathway. The implementation consists of a detailed explanation by training-materials about the clinical pathway in a selected randomized pool of PCCs. The implementation that will be evaluated is outside of the study procedures; it is the physician's decision whether to apply it or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with symptoms suggestive of GERD, managed according to a new structured and implemented pathway |
| 2 | – | –Patients with symptoms suggestive of GERD, managed according to usual clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptoms suggestive of GERD.
Key inclusion criteria (2 listed)
- Patients presenting with symptoms suggestive of GERD (heartburn or regurgitation as prevailing symptoms) of any severity
- Patient able to understand and complete the questionnaires
Key exclusion criteria (3 listed)
- Alarm symptoms (Dysphagia/odynophagia, anorexia, anaemia, unintentional weight loss, abdominal mass, upper GI bleeding)
- If the patient is participating in any clinical trial, he/she cannot take part on this study
- Any condition that, in the investigator's opinion, makes the patient's participation in the study difficult
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
Control of symptoms based on results of GerdQ, need of treatment change and % of patients requiring referral to a specialist (Austria and Italy).
Time frame: up to 8 weeks
Treatment response and symptomatic control (Norway)
Time frame: up to 8 weeks
Symptom relief and patient satisfaction with treatment (Spain)
Time frame: up to 8 weeks
Symptom relief measured by RDQ (Sweden)
Time frame: 5 months +/- 4 weeks
3 secondary outcomes
Use and consumption of healthcare resources (all countries). Physicians adherence to the clinical pathway (Austria, Spain) and intrinsic characteristics of the physicians/PCC that may affect this adherence (Austria)
Time frame: Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks
Percentage of patients referred to specialists (Spain). Health status based on EQ-5D measure (Norway, Sweden). Work productivity based on the WPAI-GERD questionnaire (Norway, Sweden)
Time frame: Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks
Sweden: Persisting symptoms according to GerdQ, Treatment changes, Reason(s) for the patient consultation at visit 1. To explore other GERD related symptoms, To describe patients' experience of treatment/care given during the study.
Time frame: 5 months +/- 4 weeks
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 23 Dec 2009.
- Derived from this study: PubMed 23426452Bergquist H, Agreus L, Tillander L, Johnsson F, Sorngard H, Sjostedt S, Hellstrom PM. Structured diagnostic and treatment approach versus the usual primary care approach in patients with gastroesophageal reflux disease: a cluster-randomized multicenter study. J Clin Gastroenterol. 2013 Aug;47(7):e65-73. doi: 10.1097/MCG.0b013e31827d7782.
- Derived from this study: PubMed 22510027Jonasson C, Moum B, Bang C, Andersen KR, Hatlebakk JG. Randomised clinical trial: a comparison between a GerdQ-based algorithm and an endoscopy-based approach for the diagnosis and initial treatment of GERD. Aliment Pharmacol Ther. 2012 Jun;35(11):1290-300. doi: 10.1111/j.1365-2036.2012.05092.x. Epub 2012 Apr 18.
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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.
Mónica Tafalla, MD study director
Medical DepartmentAstraZeneca Spain
66 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reflux and Heartburn, run by AstraZeneca at 66 sites in 5 countries.
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 2 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 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Austria, Sweden, Norway, Italy, Spain. 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?
Control of symptoms based on results of GerdQ, need of treatment change and % of patients requiring referral to a specialist (Austria and Italy). (time frame: up to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00842387, which also lists 2 linked publications.
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 23 Dec 2009.