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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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00524251
First received: August 29, 2007
Last updated: September 16, 2008
Last verified: September 2008
History of Changes
  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

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00524251     History of Changes
Other Study ID Numbers: N11
Study First Received: August 29, 2007
Last Updated: September 16, 2008
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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013