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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432392
• Other study ID #: NIS-GBG-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: September 9, 2011
• Last updated: May 9, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in intensity and frequency for each of typical GERD symptoms from baseline to week 4-6		Day 0 to week 4-6	No
Primary	Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6		Day 0 to week 4-6	No
Secondary	To evaluate the correlation between GERD-Q scores and symptom scores		two times	No