Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Inj. Compared With RCN301

Parenteral Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05299099
• Other study ID #: IN_CPN_301
• Status: Completed
• Phase: Phase 3
• Start date: May 4, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: February 2023
• Source: HK inno.N Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of IN-C006 inj. and RCN301 in postoperative patients requiring central parenteral nutrition.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parenteral Nutrition

Intervention

Drug:
• IN-C006 inj.
IN-C006 will be injected continuously for 3 days.
• RCN301
RCN301 will be injected continuously for 3 days.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Change in nutritional management parameters	Nitrogen balance(Nitrogen intake-Nitrogen out), Prealbumin(mg/L), Albumin(g/dL), Transferrin(mg/dL)	Day 1 to Day 4
Secondary	Change in inflammation parameters	hs-CRP(mg/L), TNF-a(pg/mL), IL-6(pg/mL)	Day 1 to Day 4
Secondary	Change in fatty acid profile	LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL)	Day 1 to Day 4
Secondary	Incidence of Adverse event	Rate of adverse events as assessed by CTCAE v5.0 and investigator's evaluation	Day 1 to Day 4
Secondary	Change in laboratory parameters	Hematology, Blood chemistry, Blood coagulation test, Urinalysis	Day 1 to Day 4
Secondary	Change in vital sign	Blood pressure(mmHg), pulse rate(rate), body temperature(?) and respiratory rate(rate)	Day 1 to Day 4
Secondary	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	Day 1 to Day 4