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A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 versus NTCB-P in patients who require parenteral nutrition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTCB01-1 | Experimental |
| |
| NTCB-P | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTCB01-1 | Drug | 3 Days infusion |
| |
| NTCB-P |
| Measure | Description | Time Frame |
|---|---|---|
| Occurance rate of adverse drug reaction | Day 1 to day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Hospital | Daegu | Dalseo-gu | 42601 | South Korea | ||
| Seoul Metropolitan Government Seoul National University Boramae Medical Center |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
3 Days infusion |
|
| Seoul |
| Dongjak-gu |
| 07061 |
| South Korea |
| Seoul National University Hospital | Seoul | Jongno-gu | 03080 | South Korea |
| Kosin University Gospel Hospital | Busan | Seo-gu | 49267 | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | Seocho-Gu | 06591 | South Korea |
| Korea University Anam Hospital | Seoul | Seongbuk-gu | 02841 | South Korea |
| Ajou University Medical Center | Gyeonggi-do | Suwon-si | 16499 | South Korea |