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This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia
This is a multicenter, randomized, double-blind comparative clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H.Pylori eradication therapy | Active Comparator | A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®) |
|
| Motilitone® | Experimental | 30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motilitone® | Drug |
| ||
| A-Cilin®, Clari® and Pantoline® |
| Measure | Description | Time Frame |
|---|---|---|
| Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale | 5-Likert scale
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Volunteer global assessment by using 5-Likert scale | 6 weeks | |
| The improvement rate of 4 types of dyspepsia symptoms | 12 weeks | |
| The change of each score and total score of dyspeptic symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Gyu Kim, M.D., Ph.D | Contact | 82-2-6299-3147 | jgkimd@cau.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Su Jin Hong, M.D., Ph.D. | Soonchunhyang University Hospital | Principal Investigator |
| Gwang Ha Kim, M.D., Ph.D. | Busan National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Seoul | South Korea |
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|
| 6, 12 weeks |
| Assessment of NDI-K Quality of Life | 6,12 weeks |
| The proportion of the patients who answered "yes for the question about symptom improvement | 6, 12 weeks |
| Sang Gyun Kim, M.D., Ph.D |
| Seoul National University Hospital |
| Principal Investigator |
| Hyun Soo Kim, M.D., Ph.D | Chonnam National University Hospital | Principal Investigator |
| Seong-Woo Jeon, M.D., Ph.D | Kyungpook National University Hospital | Principal Investigator |