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Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 9, 2011
Last updated: May 9, 2012
Last verified: May 2012
The purpose of this study is to evaluate the impact of gastroesophageal reflux disease (GERD) treatment in primary care setting on symptom control and daily life in symptomatic GERD patients, using both GERD questionnaire and clinical symptoms assessment

Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percent change in intensity and frequency for each of typical GERD symptoms from baseline to week 4-6 [ Time Frame: Day 0 to week 4-6 ]
  • Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6 [ Time Frame: Day 0 to week 4-6 ]

Secondary Outcome Measures:
  • To evaluate the correlation between GERD-Q scores and symptom scores [ Time Frame: two times ]

Enrollment: 1000
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Detailed Description:
A prospective, observational study to describe symptom control and impact on daily life in patients with gastroesophageal reflux disease (GERD)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care setting

Inclusion Criteria:

  • Patients known or newly diagnosed with GERD
  • Patients with typical GERD symptoms as heartburn and regurgitation for ≥2 days in the previous week
  • Patients, currently not treated with a proton pump inhibitor

Exclusion Criteria:

  • Patients who have been receiving treatment with non-steroidal antiinflammatory drugs within two weeks prior the inclusion in the study
  • Patients with medical history of surgery of the esophagus, stomach or duodenum
  • Pregnant or nursing females
  Contacts and Locations
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Please refer to this study by its identifier: NCT01432392

Sofia, Bulgaria
Varna, Bulgaria
Sponsors and Collaborators
  More Information

Responsible Party: AstraZeneca Identifier: NCT01432392     History of Changes
Other Study ID Numbers: NIS-GBG-XXX-2011/1
Study First Received: September 9, 2011
Last Updated: May 9, 2012

Keywords provided by AstraZeneca:
gastroesophageal reflux disease
GERD questionnaire
primary care setting

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on May 25, 2017