- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00524251
The Effect of Lifestyle-Adjustments Prior to Medical Treatment on the Effect of Medical Treatment in Reflux Patients
September 16, 2008 updated by: AstraZeneca
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 Overview
Study Type
Observational
Enrollment (Anticipated)
990
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Almere, Netherlands
- Research Site
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Apeldoorn, Netherlands
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Baarn, Netherlands
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Bennebroek, Netherlands
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Blaardingen, Netherlands
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Boekel, Netherlands
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Bunschoten Spakenburg, Netherlands
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Delft, Netherlands
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Den Haag, Netherlands
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Enschede, Netherlands
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Ewijk, Netherlands
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Geleen, Netherlands
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Haelen, Netherlands
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Halfweg NH, Netherlands
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Hardenberg, Netherlands
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Heemstede, Netherlands
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Hillegom, Netherlands
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Hilversum, Netherlands
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Horst, Netherlands
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Kerkrade, Netherlands
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Klimmen, Netherlands
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Landgraaf, Netherlands
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Laren, Netherlands
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Leusden, Netherlands
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Lichtenvoorde, Netherlands
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Lisse, Netherlands
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Maastricht, Netherlands
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Monster, Netherlands
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Nieuw Vennep, Netherlands
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Nieuwegein, Netherlands
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Nijverdal, Netherlands
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Ochten, Netherlands
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Oisterwijk, Netherlands
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Oldenzaal, Netherlands
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Pijnacker, Netherlands
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Rijnsburg, Netherlands
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Rijssen, Netherlands
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Schijndel, Netherlands
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Sittard, Netherlands
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Soest, Netherlands
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Susteren, Netherlands
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Swalmen, Netherlands
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Tilburg, Netherlands
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Vaals, Netherlands
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Valkenburg, Netherlands
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Veenendaall, Netherlands
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Velp, Netherlands
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Warnsveld, Netherlands
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Wassenaar, Netherlands
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Westerhaar-Vrienzenv Wijk, Netherlands
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Zandvoort, Netherlands
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Zevenhuizen, Netherlands
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Zoetermeer, Netherlands
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s-Gravenzande, Netherlands
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with reflux complaints
- 18 years of age
Exclusion Criteria:
- Restrictions as mentioned in the registration text
- H2RA or PPI use in the month prior to inclusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: N van den Berk, AstraZeneca
- Study Director: A Sellink, MD, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
August 29, 2007
First Submitted That Met QC Criteria
August 31, 2007
First Posted (Estimate)
September 3, 2007
Study Record Updates
Last Update Posted (Estimate)
September 17, 2008
Last Update Submitted That Met QC Criteria
September 16, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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