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

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

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sofia, Bulgaria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

To evaluate the correlation between GERD-Q scores and symptom scores

Time frame: two times

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Prospective, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Sep 13, 2011
Registry last updated: May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed