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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01432392
Enrollment
1000
Registered
2011-09-13
Start date
2011-09-30
Completion date
2012-04-30
Last updated
2012-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

gastroesophageal reflux disease, GERD questionnaire, primary care setting

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

Detailed description

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

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percent change in intensity and frequency for each of typical GERD symptoms from baseline to week 4-6Day 0 to week 4-6
Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6Day 0 to week 4-6

Secondary

MeasureTime frame
To evaluate the correlation between GERD-Q scores and symptom scorestwo times

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026