Evaluation of symptom relief in functional dyspepsia patients with PPI-resistant Gastroesophageal reflux disease -Acotiamide + standard-dose PPI vs double-dose PPI ; Prospective multi-center randomized study
Not Applicable
- Conditions
- Functional Dyspepsia patients with PPI-resistant Gastroesophageal reflux disease
- Registration Number
- JPRN-UMIN000014082
- Lead Sponsor
- Osaka Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients taking Gastric secretion inhibitors except Rabeprazole, Prokinetic agents except Acotiamide, and Chinese gastrointestinal medicine(Rikkunsito) after taking experimental drugs "study treatment" 2) Patients who received total gastrectomy 3) Patients with a chief complaint of IBS 4) Patients contraindicated for study treatment 5) Patients under 20 years old 6) Patients unsuited for this study at a physician's discretion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of responder rate defined as >=50% decrease in the Izumo Scale between groups
- Secondary Outcome Measures
Name Time Method 1) Responder rate defined as >=50% decrease in the total score of 3 upper abdominal symptoms (heartburn, gastralgia, and epigastric fullness of the Izumo Scale (comparison between groups) 2) Change in each symptom score (total/3 upper abdominal symptoms/heartburn/gastralgia/epigastric fullness/constipation/diarrhea) of Izumo Scale a) Comparison of change in score between groups b) Comparison of change in score between pre-dose and post dose c) Sub-analysis of above a) and b) by patient demographics (including gender, age, H. pylori and BMI) 3) Change in revised F scale score (total score/FD score/GERD score) a) Comparison of change in score between groups b) Comparison of change in score between pre-dose and post dose c) Sub-analysis of above a) and b) by patient demographics (including gender, age, H. pylori and BMI) 4)Adverse event