Gastroesophageal Reflux Disease
Conditions
Keywords
GERD, PPI, partial responders
Brief summary
The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.
Interventions
None listed
Sponsors
i3 Innovus
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 6 month history of GERD symptoms * Treated with unchanged optimized PPI treatment for any GERD indication during the last 4 weeks before enrollment * Remaining GERD symptoms despite optimized PPI treatment * Able to read and write in French, and able to comply with study requirements
Exclusion criteria
* Patients that have not experienced any GERD symptom improvement at all during PPI treatment * Involvement in the planning or conduct of the study * Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months * Prior surgery of the upper GI tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Utility values; Quality of Life | Collected at enrollment visit and at 6 and 12 month follow-up. |
| Productivity loss; Frequency and severity of GERD symptoms; Health care resource use | Collected at enrollment visit and at 3, 6, 9 and 12 month follow-up. (Health care resource use is collected by the physician at enrollment visit and 6 and 12 month follow-up) |
Countries
France
Outcome results
None listed