Status:
COMPLETED
Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Inj. Compared With RCN301
Lead Sponsor:
HK inno.N Corporation
Conditions:
Parenteral Nutrition
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the safety and efficacy of IN-C006 inj. and RCN301 in postoperative patients requiring central parenteral nutrition.
Detailed Description
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)
Eligibility Criteria
Inclusion
- Age over 19 at the time of obtaining the informed consent form
- Requiring over 3 days of parenteral nutrition via a central vein after an operation
- BMI 16 \~ 30 kg/㎡
Exclusion
- Has received parenteral nutrition within 7 days of screening
- Severe dyslipidemia
- Uncontrolled diabetes
- Clinically significant liver disease
- Clinically significant kidney disease
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05299099
Start Date
May 4 2022
End Date
December 15 2022
Last Update
September 28 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea