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The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.
A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase â…¢ Study to Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal Reflux Disease(NERD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIP1601 Amg | Experimental | The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks. |
|
| HGP1805 | Placebo Comparator | The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIP1601 | Drug | HIP1601 |
| |
| HGP1805 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with complete resolution of major symptoms at 4-week | Complete resolution is defined as no episodes of symptom during the last 7 days of treatment. | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with complete resolution of major symptoms at 2-week | Complete resolution is defined as no episodes of symptom during the last 7 days of treatment | 2 week |
| Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| Drug |
Placebo of HIP1601 |
|
RDQ frequncy and severity score is 0 to 5 point scale, high score mean a worse outcome. |
| 2, 4 week |
| Time to complete resolution of major symptoms | defined as time to the first day of complete resolution | 4 week |
| Resolution rate of major symptoms of first 7 days | defined as first of 7 days with no episodes of symptom using subject's diary | 1 week |
| Major symptoms-Free days | Major symptoms-Free days mean rate of days that symtom's severity score is '0' using subject's diary | 1, 4 week |
| Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL) | PAGI-QoL total score is 0 to 30 point scale, high score mean a better outcome. | 4 week |
| Proportion of rescue medication amounts | Use of rescue medication | 4 week |