Gastroesophageal Reflux DiseaseREMAINNCT00842855
Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient - a Study in France
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 44 sites in France.
Trial summary
The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 275 participants
- Where
- 44 sitesFrance
- Study dates
- Feb 2009to Nov 2010
- 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 Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).
Who may be able to join
- At least 6 month history of GERD symptoms
- Treated with unchanged optimized PPI treatment for any GERD indication during the last 4 weeks before enrollment
- Remaining GERD symptoms despite optimized PPI treatment
- Able to read and write in French, and able to comply with study requirements
Who cannot join
- Patients that have not experienced any GERD symptom improvement at all during PPI treatment
- Involvement in the planning or conduct of the study
- Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months
- Prior surgery of the upper GI tract
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
France44 sites
Research Site
Bandol
Research Site
Beaumont-sur-Oise
Research Site
Beausoleil
Research Site
Behren-lès-Forbach
Research Site
Berck
Research Site
Bièvres
Research Site
Bordeaux
Research Site
Bressuire
Research Site
Brest
Research Site
Cambrai
Research Site
Chalon-sur-Saône
Research Site
Colmar
Research Site
Cornebarrieu
Research Site
Creil
Research Site
Créteil
Research Site
Dieppe
Research Site
Freyming-Merlebach
Research Site
Gien
Research Site
Hagondange
Research Site
Ivoy-le-Pré
Research Site
La Garde
Research Site
La Rochelle
Research Site
La Seyne-sur-Mer
Research Site
Le Lavandou
Research Site
Lyon
Research Site
Marseille
Research Site
Mont-de-Marsan
Research Site
Nice
Research Site
Paris
Research Site
Rouen
Research Site
Saint-Cyr-sur-Mer
Research Site
Saint-Jeannet
Research Site
Saint-Mandé
Research Site
Saint-Mandrier-sur-Mer
Research Site
Sanary-sur-Mer
Research Site
Six-Fours-les-Plages
Research Site
Stiring-Wendel
Research Site
Toulon
Research Site
Toulouse
Research Site
Toussieu
Research Site
Venerque
Research Site
Verdun
Research Site
Versailles
Research Site
Witry-lès-Reims
About this study
Official title: Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient
The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, PPI, partial responders
- 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 | 274 GERD patients, partial responders to PPI treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Productivity loss; Frequency and severity of GERD symptoms; Health care resource use
Measured: Collected at enrollment visit and at 3, 6, 9 and 12 month follow-up. (Health care resource use is collected by the physician at enrollment visit and 6 and 12 month follow-up)
Utility values; Quality of Life
Measured: Collected at enrollment visit and at 6 and 12 month follow-up.
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 startFeb 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- i3 Innovus
- Investigators
- Pr Stanislas Bruley des Varannes, MD PhD, Principal investigator, Institut des Maladies de l'Appareil digestifMarie Sundin, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842855
- Sponsor's protocol ID
- D9120N00013
- Acronym
- REMAIN
- Status last verified
- Feb 2011
- First submitted
- 11 Feb 2009
- Last updated
- 7 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient
- ClinicalTrials.gov ID
- NCT00842855
- Acronym / sponsor ID
- REMAIN / D9120N00013
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, PPI, partial responders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- i3 Innovus
- Study start
- Feb 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (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 purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –274 GERD patients, partial responders to PPI treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).
Key inclusion criteria (4 listed)
- At least 6 month history of GERD symptoms
- Treated with unchanged optimized PPI treatment for any GERD indication during the last 4 weeks before enrollment
- Remaining GERD symptoms despite optimized PPI treatment
- Able to read and write in French, and able to comply with study requirements
Key exclusion criteria (4 listed)
- Patients that have not experienced any GERD symptom improvement at all during PPI treatment
- Involvement in the planning or conduct of the study
- Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months
- Prior surgery of the upper GI tract
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
Productivity loss; Frequency and severity of GERD symptoms; Health care resource use
Time frame: Collected at enrollment visit and at 3, 6, 9 and 12 month follow-up. (Health care resource use is collected by the physician at enrollment visit and 6 and 12 month follow-up)
Utility values; Quality of Life
Time frame: Collected at enrollment visit and at 6 and 12 month follow-up.
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 Feb 2011.
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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.
Pr Stanislas Bruley des Varannes, MD PhD principal investigator
Institut des Maladies de l'Appareil digestif
Marie Sundin study director
AstraZeneca
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 44 sites in France.
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 4 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 7 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in France. 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?
Productivity loss; Frequency and severity of GERD symptoms; Health care resource use (time frame: Collected at enrollment visit and at 3, 6, 9 and 12 month follow-up. (Health care resource use is collected by the physician at enrollment visit and 6 and 12 month follow-up)). The study lists 2 primary outcomes in all. 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 7 Feb 2011.