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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01432392
First received: September 9, 2011
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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
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 ] [ Designated as safety issue: No ]
  • Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6 [ Time Frame: Day 0 to week 4-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the correlation between GERD-Q scores and symptom scores [ Time Frame: two times ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432392

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov 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
Health Authority: Bulgaria: Bulgarian Drug Agency

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

ClinicalTrials.gov processed this record on August 18, 2014