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

September 25, 2023 updated by: HK inno.N Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IN-C006 inj.
IN-C006 inj. 1970 mL
Drug: IN-C006 inj.
IN-C006 will be injected continuously for 3 days.
Other Names:
  • IN-C006 inj
Active Comparator: RCN301
RCN301 1820 mL
Drug: RCN301
RCN301 will be injected continuously for 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse drug reaction rate
Time Frame: Day 1 to Day 4
Rate of treatment-related adverse events as assessed by CTCAE v5.0 and investigator's evaluation
Day 1 to Day 4

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HK inno.N Corporation

Investigators

  • Study Chair: Do Joong PARK, Seoul National Univerity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2022

Primary Completion (Actual)

December 9, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IN_CPN_301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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