Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Proton-Pump Inhibitors (PPI) Treatment
Completed
- Conditions
- Gastroesophageal Reflux
- Registration Number
- NCT01103804
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary objective of the study is to describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(using GerdQ questionnaire). The secondary objectives are: to measure the response at the current treatment after a 4-week period of systematic treatment and to identify the percentage of patients which require alterations of their treatment (GerdQ questionnaire)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 952
Inclusion Criteria
- Provision of informed consent
- Patients known or newly diagnosed with GERD or patients with typical symptoms of GERD- heartburn, regurgitation (in the last case, GerdQ sum score should be ≥8, in the absence of PPI treatment)
Exclusion Criteria
- Any symptoms at visit 1 suggesting a need for further investigation, judged by the Investigator (alarm symptoms).The alarm symptoms suggesting complicated disease are: dysphagia, odynophagia, bleeding, weight loss without intention or anemia.
- Previous participation in the present study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(GerdQ) 4 weeks(at V1 and V2)
- Secondary Outcome Measures
Name Time Method measure the response at the current treatment after a 4-week period of systematic treatment with PPIs(GerdQ) 4 weeks(at V1 and V2) identify the percentage of patients which require alterations of their treatment after a 4-week period of systematic treatment with PPIs(GerdQ) 4 weeks(at V1 and V2)
Trial Locations
- Locations (1)
Research Site
🇷🇴Vanatori(GL), Romania