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The Effect of Lifestyle-Adjustments Prior to Medical Treatment on the Effect of Medical Treatment in Reflux Patients

This study has been completed.

Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00524251
  Purpose

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)


Condition Intervention
GERD
Quality of Life
Drug: esomeprazole

ChemIDplus related topics:   Esomeprazole magnesium    Esomeprazole Sodium    Omeprazole    Omeprazole magnesium   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective

Further study details as provided by AstraZeneca:

Estimated Enrollment:   990
Study Start Date:   June 2004
Study Completion Date:   March 2008

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524251

Show 54 study locations  Show 54 Study Locations

Sponsors and Collaborators
AstraZeneca

Investigators
Study Director:     A Sellink, MD     AstraZeneca    
Study Chair:     N van den Berk     AstraZeneca    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   N11
First Received:   August 29, 2007
Last Updated:   September 16, 2008
ClinicalTrials.gov Identifier:   NCT00524251
Health Authority:   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:
Patients with reflux complaints  
GERD  
quality of life  
lifestyle adjustments  

Study placed in the following topic categories:
Omeprazole
Quality of Life

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008




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