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This study will evaluate the efficacy and safety of DA-9701 in patients with functional dyspepsia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-9701 | Experimental | administered for 4weeks(DA-9701 + DA-9701-R placebo) |
|
| DA-9701-R | Active Comparator | administered for 4weeks(DA-9701-R + DA-9701 placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-9701 | Drug | 1 tablet, TID |
| |
| DA-9701-R |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in GIS(Gastrointestinal Symptom Score) total scores | Change from baseline at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in GIS(Gastrointestinal Symptom Score) total scores | Change from baseline at 2 weeks | |
| Changes in GIS(Gastrointestinal Symptom Score) scores by symptoms | Change from baseline at 2 weeks and 4 weeks |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang Kil Lee | Contact | +82) 02-2228-4000 | SKLEE@yuhs.ac |
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| ID | Term |
|---|---|
| C533973 | DA-9701 |
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| Drug |
1 tablet, TID |
|
| DA-9701 Placebo | Drug | 1 tablet, TID |
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| DA-9701-R Placebo | Drug | 1 tablet, TID |
|
| Changes in NDI-K QoL(Nepean Dyspepsia Index-Korean version Quality of Life) domain scores and total scores | Change from baseline at 4 weeks |
| Subject's global assessment | at week 4 |
| Investigator's global assessment | at week 4 |