Non-Erosive Reflux Disease (NERD) Digestive System Non-Erosive Reflux Disease (NERD)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 20 and over 2. Heartburn (more than 6 points diagnosed by the Japanese version of questionnaire for the diagnosis of reflux disease [QUEST]) 3. Signed a study-specific informed consent form
Exclusion criteria
Exclusion criteria: 1. Endoscopic esophagitis 2. Gastric and duodenal ulcers, stomach cancer, or acute gastritis 3. Known hypersensitivity to rebamipide 4. Catastrophic complications 5. Pregnancy or desire to become pregnant 6. Judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The subjective symptoms are assessed by the Japanese version QUEST and Gastrointestinal Symptom Rating Scale (GSRS). The assessment by GSRS is limited to upper gastrointestinal tract questions. These will be measured at baseline, 1 month after PPI therapy and 1 month after repamipide or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients who complete the study protocol. | — |
Countries
Japan