Clinical trial
A Randomized, Open-label, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Inj. Compared With RCN301 in Postoperative Patients Requiring Central Parenteral Nutrition
Name
IN_CPN_301
Description
This study is designed to evaluate the safety and efficacy of IN-C006 inj. and RCN301 in postoperative patients requiring central parenteral nutrition.
Trial arms
Trial start
2022-05-04
Estimated PCD
2022-12-09
Trial end
2022-12-15
Status
Completed
Phase
Early phase I
Treatment
IN-C006 inj.
IN-C006 will be injected continuously for 3 days.
Arms:
IN-C006 inj.
Other names:
IN-C006 inj
RCN301
RCN301 will be injected continuously for 3 days.
Arms:
RCN301
Size
60
Primary endpoint
Adverse drug reaction rate
Day 1 to Day 4
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* Has received parenteral nutrition within 7 days of screening
* Severe dyslipidemia
* Uncontrolled diabetes
* Clinically significant liver disease
* Clinically significant kidney disease
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-09-28
1 organization
2 products
1 indication
Organization
HK inno.N CorporationProduct
IN-C006Indication
Parenteral nutritionProduct
RCN301