Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
Completed
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Registration Number
- NCT00795093
- 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
- 552
Inclusion Criteria
- At least 6 month history of GERD symptoms
- Treated with unchanged optimized PPI treatment for any GERD indication during a consecutive 4 week period
- Remaining GERD symptoms despite optimized PPI treatment
- Able to read and write in US English, 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months) Utility values Collected at enrollment visit and at 6 month follow-up.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms underlying partial response to PPIs in GERD patients as studied in NCT00795093?
How does PPI treatment efficacy in NCT00795093 compare to standard-of-care therapies for GERD?
What biomarkers correlate with partial response to PPIs in GERD as identified in AstraZeneca's NCT00795093 study?
What adverse events are associated with long-term PPI use in GERD partial responders according to NCT00795093 data?
How do alternative acid suppression therapies compare to PPIs in managing GERD symptoms for non-responders identified in NCT00795093?
Trial Locations
- Locations (1)
Research Site
🇺🇸West Jordan, Utah, United States
Research Site🇺🇸West Jordan, Utah, United States