GERDNCT00524251
The Effect of Lifestyle-Adjustments Prior to Medical Treatment on the Effect of Medical Treatment in Reflux Patients
An observational study of GERD and Quality of Life, run by AstraZeneca at 54 sites in Netherlands.
Trial summary
The purpose of this study is to determine whether the improvement in the quality of life after an initial treatment with esomeprazole 40mg for reflux disease is the same in patients who have already made lifestyle-adjustments as in patients who have not implemented lifestyle-adjustments prior to the start of treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD, Quality of Life
- What is being tested?
- esomeprazole
- How many people
- 990 participants
- Where
- 54 sitesNetherlands
- Study dates
- Jun 2004to Mar 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
Who may be able to join
- Patients with reflux complaints
- 18 years of age
Who cannot join
- Restrictions as mentioned in the registration text
- H2RA or PPI use in the month prior to inclusion
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Netherlands54 sites
Research Site
's-Gravenzande
Research Site
Almere Stad
Research Site
Apeldoorn
Research Site
Baarn
Research Site
Bennebroek
Research Site
Blaardingen
Research Site
Boekel
Research Site
Delft
Research Site
Enschede
Research Site
Ewijk
Research Site
Geleen
Research Site
Haelen
Research Site
Halfweg NH
Research Site
Hardenberg
Research Site
Heemstede
Research Site
Hillegom
Research Site
Hilversum
Research Site
Horst
Research Site
Kerkrade
Research Site
Klimmen
Research Site
Landgraaf
Research Site
Laren
Research Site
Leusden
Research Site
Lichtenvoorde
Research Site
Lisse
Research Site
Maastricht
Research Site
Monster
Research Site
Nieuw-Vennep
Research Site
Nieuwegein
Research Site
Nijverdal
Research Site
Ochten
Research Site
Oisterwijk
Research Site
Oldenzaal
Research Site
Pijnacker
Research Site
Rijnsburg
Research Site
Rijssen
Research Site
Schijndel
Research Site
Sittard
Research Site
Soest
Research Site
Spakenburg
Research Site
Susteren
Research Site
Swalmen
Research Site
The Hague
Research Site
Tilburg
Research Site
Vaals
Research Site
Valkenburg
Research Site
Veenendaall
Research Site
Velp
Research Site
Warnsveld
Research Site
Wassenaar
Research Site
Westerhaar-Vrienzenv Wijk
Research Site
Zandvoort
Research Site
Zevenhuizen
Research Site
Zoetermeer
About this study
The purpose of this study is to determine whether the improvement in the quality of life after an initial treatment with esomeprazole 40mg for reflux disease is the same in patients who have already made lifestyle-adjustments as in patients who have not implemented lifestyle-adjustments prior to the start of treatment (baseline)
- Conditions
- GERD, Quality of Life
- Being tested
- esomeprazole
- Keywords
- Patients with reflux complaints, GERD, quality of life, lifestyle adjustments
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startJun 2004
- Study completionMar 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
- Prospective
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- A Sellink, MD, Study director, AstraZenecaN van den Berk, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524251
- Sponsor's protocol ID
- N11
- Status last verified
- Sep 2008
- First submitted
- 29 Aug 2007
- Last updated
- 17 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lifestyle-Adjustments Prior to Medical Treatment on the Effect of Medical Treatment in Reflux Patients
- ClinicalTrials.gov ID
- NCT00524251
- Acronym / sponsor ID
- N11
- Conditions
- GERD, Quality of Life
- Keywords
- Patients with reflux complaints, GERD, quality of life, lifestyle adjustments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Mar 2008 (actual)
- First posted
- 3 Sep 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.
The purpose of this study is to determine whether the improvement in the quality of life after an initial treatment with esomeprazole 40mg for reflux disease is the same in patients who have already made lifestyle-adjustments as in patients who have not implemented lifestyle-adjustments prior to the start of treatment (baseline)
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with reflux complaints
- 18 years of age
Key exclusion criteria (2 listed)
- Restrictions as mentioned in the registration text
- H2RA or PPI use in the month prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esomeprazole | Drug | – |
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 17 Sep 2008.
Related trials for GERD
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RETHINK REFLUX Registry
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Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
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Not yet recruitingPhase 4
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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.
A Sellink, MD study director
AstraZeneca
N van den Berk study chair
AstraZeneca
54 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 and Quality of Life, run by AstraZeneca at 54 sites in Netherlands.
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 2 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 17 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Netherlands. 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 17 Sep 2008.