Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient - a Study in France
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Registration Number
- NCT00842855
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) Utility values; Quality of Life Collected at enrollment visit and at 6 and 12 month follow-up.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇫🇷Witry les Reims, France