Clinical trial NCT05337228: Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301
Official title: A Randomized, Open-label, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301 in Postoperative Patients Requiring Peripheral Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parenteral Nutrition
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2022-04-20
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 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 Peri inj. or RPN301)

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 peripheral 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

Primary outcomes:
measure: Adverse drug reaction rate
timeFrame: Day 1 to Day 4
Secondary outcomes:
measure: Change in nutritional management parameters(Nitrogen balance)
timeFrame: Day 1 to Day 4
measure: Change in nutritional management parameters(Prealbumin)
timeFrame: Day 1 to Day 4
measure: Change in nutritional management parameters(Albumin)
timeFrame: Day 1 to Day 4
measure: Change in nutritional management parameters(Transferrin)
timeFrame: Day 1 to Day 4
measure: Change in inflammation parameters(hs-CRP)
timeFrame: Day 1 to Day 4
measure: Change in inflammation parameters(TNF-α)
timeFrame: Day 1 to Day 4
measure: Change in inflammation parameters(IL-6)
timeFrame: Day 1 to Day 4
measure: Change in fatty acid profile
timeFrame: Day 1 to Day 4
measure: Incidence of Adverse event
timeFrame: Day 1 to Day 4
measure: Change in laboratory parameters (Hematology)
timeFrame: Day 1 to Day 4
measure: Change in laboratory parameters (Blood chemistry)
timeFrame: Day 1 to Day 4
measure: Change in laboratory parameters (Blood coagulation test)
timeFrame: Day 1 to Day 4
measure: Change in laboratory parameters (Urinalysis)
timeFrame: Day 1 to Day 4
measure: Change in vital sign (Blood pressure)
timeFrame: Day 1 to Day 4
measure: Change in vital sign (Pulse rate)
timeFrame: Day 1 to Day 4
measure: Change in vital sign (Body temperature)
timeFrame: Day 1 to Day 4
measure: Change in vital sign (Respiratory rate)
timeFrame: Day 1 to Day 4
measure: Normal and abnormal change in physical examination (Frequency)
timeFrame: Day 1 to Day 4
measure: Normal and abnormal change in physical examination (Ratio)
timeFrame: Day 1 to Day 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National Univerity Hospital
name: Do Joong PARK
role: STUDY_CHAIR
References: