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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Netherlands
      • Almere, Netherlands
        • Research Site
      • Apeldoorn, Netherlands
        • Research Site
      • Baarn, Netherlands
        • Research Site
      • Bennebroek, Netherlands
        • Research Site
      • Blaardingen, Netherlands
        • Research Site
      • Boekel, Netherlands
        • Research Site
      • Bunschoten Spakenburg, Netherlands
        • Research Site
      • Delft, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Enschede, Netherlands
        • Research Site
      • Ewijk, Netherlands
        • Research Site
      • Geleen, Netherlands
        • Research Site
      • Haelen, Netherlands
        • Research Site
      • Halfweg NH, Netherlands
        • Research Site
      • Hardenberg, Netherlands
        • Research Site
      • Heemstede, Netherlands
        • Research Site
      • Hillegom, Netherlands
        • Research Site
      • Hilversum, Netherlands
        • Research Site
      • Horst, Netherlands
        • Research Site
      • Kerkrade, Netherlands
        • Research Site
      • Klimmen, Netherlands
        • Research Site
      • Landgraaf, Netherlands
        • Research Site
      • Laren, Netherlands
        • Research Site
      • Leusden, Netherlands
        • Research Site
      • Lichtenvoorde, Netherlands
        • Research Site
      • Lisse, Netherlands
        • Research Site
      • Maastricht, Netherlands
        • Research Site
      • Monster, Netherlands
        • Research Site
      • Nieuw Vennep, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Nijverdal, Netherlands
        • Research Site
      • Ochten, Netherlands
        • Research Site
      • Oisterwijk, Netherlands
        • Research Site
      • Oldenzaal, Netherlands
        • Research Site
      • Pijnacker, Netherlands
        • Research Site
      • Rijnsburg, Netherlands
        • Research Site
      • Rijssen, Netherlands
        • Research Site
      • Schijndel, Netherlands
        • Research Site
      • Sittard, Netherlands
        • Research Site
      • Soest, Netherlands
        • Research Site
      • Susteren, Netherlands
        • Research Site
      • Swalmen, Netherlands
        • Research Site
      • Tilburg, Netherlands
        • Research Site
      • Vaals, Netherlands
        • Research Site
      • Valkenburg, Netherlands
        • Research Site
      • Veenendaall, Netherlands
        • Research Site
      • Velp, Netherlands
        • Research Site
      • Warnsveld, Netherlands
        • Research Site
      • Wassenaar, Netherlands
        • Research Site
      • Westerhaar-Vrienzenv Wijk, Netherlands
        • Research Site
      • Zandvoort, Netherlands
        • Research Site
      • Zevenhuizen, Netherlands
        • Research Site
      • Zoetermeer, Netherlands
        • Research Site
      • s-Gravenzande, Netherlands
        • Research Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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