This study is designed to evaluate the safety and efficacy of IN-C006 inj. and RCN301 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 inj. or RCN301)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
IN-C006 will be injected continuously for 3 days.
RCN301 will be injected continuously for 3 days.
Seoul National University Hospital
Seoul, South Korea
Adverse drug reaction rate
Rate of treatment-related adverse events as assessed by CTCAE v5.0 and investigator's evaluation
Time frame: Day 1 to Day 4
Change in nutritional management parameters
Nitrogen balance(Nitrogen intake-Nitrogen out), Prealbumin(mg/L), Albumin(g/dL), Transferrin(mg/dL)
Time frame: Day 1 to Day 4
Change in inflammation parameters
hs-CRP(mg/L), TNF-α(pg/mL), IL-6(pg/mL)
Time frame: Day 1 to Day 4
Change in fatty acid profile
LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL)
Time frame: Day 1 to Day 4
Incidence of Adverse event
Rate of adverse events as assessed by CTCAE v5.0 and investigator's evaluation
Time frame: Day 1 to Day 4
Change in laboratory parameters
Hematology, Blood chemistry, Blood coagulation test, Urinalysis
Time frame: Day 1 to Day 4
Change in vital sign
Blood pressure(mmHg), pulse rate(rate), body temperature(℃) and respiratory rate(rate)
Time frame: Day 1 to Day 4
Normal and abnormal change in physical examination
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
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Time frame: Day 1 to Day 4