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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01432392
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : May 10, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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

Condition or disease
Gastroesophageal Reflux Disease

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

Study Type : Observational
Actual Enrollment : 1000 participants
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)
Study Start Date : September 2011
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Group/Cohort
1



Primary Outcome Measures :
  1. 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 ]
  2. Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6 [ Time Frame: Day 0 to week 4-6 ]

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


Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432392


Locations
Bulgaria
Sofia, Bulgaria
Varna, Bulgaria
Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01432392     History of Changes
Other Study ID Numbers: NIS-GBG-XXX-2011/1
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 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