Functional Dyspepsia patients with PPI-resistant Gastroesophageal reflux disease
Conditions
Interventions
Acotiamide 300mg/day and Rabeprazole 10mg/day
Rabeprazole 20mg/day
Sponsors
Osaka Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient with the following symptoms ( a) and b)) even if they take usual dose PPI* for >=8 weeks a) At least one symptom score is "slightly uncomfortable" or worsen in the 3 heartburn-related symptoms b) At least one symptom score is "slightly uncomfortable" or worsen in the 3 epigastric fullness-related symptoms 2) GERD Patients with >=Grade M classified by revision Los Angeles classification even if they take usual dose PPI* for >=8 weeks 3) Patients taking usual dose PPI* until just before taking experimental drugs "study treatment" 4) Patients diagnosed as FD with upper gastrointestinal endoscopy during the past year before giving written informed consent 5) Patients giving written informed consent of this study * usual dose PPI: Rabeprazole 10mg/day, Lansoprazole 30mg/day, Esomeprazole 20mg/day, Omeprazole 20mg/day
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of responder rate defined as >=50% decrease in the Izumo Scale between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactStudy support center
Quintiles Transnational Japan K.K. Medical & regulatory affairs division
Outcome results
None listed