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This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 in postoperative patients requiring central parenteral nutrition.
This study is a randomized, open-label, phase 3 design. The subject will be assigned to one of the two treatment groups (IN-C006 Peri inj. or RPN301)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IN-C006 Peri inj. | Experimental | IN-C006 Peri inj. 1904 mL |
|
| RPN301 | Active Comparator | RPN301 2020 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN-C006 Peri inj. | Drug | IN-C006 peri inj. will be injected continuously for 3 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug reaction rate | Rate of treatment-related adverse events as assessed by CTCAE v5.0 and investigator's evaluation | Day 1 to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nutritional management parameters(Nitrogen balance) | Nitrogen balance(Nitrogen intake-Nitrogen out) | Day 1 to Day 4 |
| Change in nutritional management parameters(Prealbumin) | Prealbumin(mg/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Do Joong PARK | Seoul National Univerity Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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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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| RPN301 |
| Drug |
RPN301 will be injected continuously for 3 days. |
|
| Day 1 to Day 4 |
| Change in nutritional management parameters(Albumin) | Albumin(g/dL) | Day 1 to Day 4 |
| Change in nutritional management parameters(Transferrin) | Transferrin(mg/dL) | Day 1 to Day 4 |
| Change in inflammation parameters(hs-CRP) | hs-CRP(mg/L) | Day 1 to Day 4 |
| Change in inflammation parameters(TNF-α) | TNF-α(pg/mL) | Day 1 to Day 4 |
| Change in inflammation parameters(IL-6) | IL-6(pg/mL) | Day 1 to Day 4 |
| Change in fatty acid profile | LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL) | Day 1 to Day 4 |
| Incidence of Adverse event | Rate of adverse events as assessed by CTCAE v5.0 and investigator's evaluation | Day 1 to Day 4 |
| Change in laboratory parameters (Hematology) | Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group - Hematology | Day 1 to Day 4 |
| Change in laboratory parameters (Blood chemistry) | Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group - Blood chemistry | Day 1 to Day 4 |
| Change in laboratory parameters (Blood coagulation test) | Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group - Blood coagulation test | Day 1 to Day 4 |
| Change in laboratory parameters (Urinalysis) | Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group - Urinalysis | Day 1 to Day 4 |
| Change in vital sign (Blood pressure) | Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) - Systolic blood pressure(mmHg), Diastolic blood pressure(mmHg) | Day 1 to Day 4 |
| Change in vital sign (Pulse rate) | Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) - Pulse rate(rate) | Day 1 to Day 4 |
| Change in vital sign (Body temperature) | Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) - Body temperature(℃) | Day 1 to Day 4 |
| Change in vital sign (Respiratory rate) | Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) - Respiratory rate(rate) | Day 1 to Day 4 |
| Normal and abnormal change in physical examination (Frequency) | Frequency of subjects who were normal/clinically insignificant abnormalities before administration of investigational products to clinically significant abnormalities at least once after administration of investigational products - General Appearance, HEENT (Head, Eyes, Ears, Nose, Throat), Skin (including hair, nails), Respiratory, Cardiovascular, Chest/Lungs/Breast, Abdominal/Gastrointestinal, Musculoskeletal, Extremities/Joint, Neurological/Psychological, Lymph nodes, Rectal/Pelvic/Genitalia, Other | Day 1 to Day 4 |
| Normal and abnormal change in physical examination (Ratio) | Ratio of subjects who were normal/clinically insignificant abnormalities before administration of investigational products to clinically significant abnormalities at least once after administration of investigational products - General Appearance, HEENT (Head, Eyes, Ears, Nose, Throat), Skin (including hair, nails), Respiratory, Cardiovascular, Chest/Lungs/Breast, Abdominal/Gastrointestinal, Musculoskeletal, Extremities/Joint, Neurological/Psychological, Lymph nodes, Rectal/Pelvic/Genitalia, Other | Day 1 to Day 4 |