NCT05299099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 4, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

September 28, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

March 2, 2022

Last Update Submit

September 25, 2023

Conditions

Parenteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in nutritional management parameters

    Day 1 to Day 4

  • Change in inflammation parameters

    Day 1 to Day 4

  • Change in fatty acid profile

    Day 1 to Day 4

  • Incidence of Adverse event

    Day 1 to Day 4

  • Change in laboratory parameters

    Day 1 to Day 4

  • +2 more secondary outcomes

Study Arms (2)

IN-C006 inj.

EXPERIMENTAL

IN-C006 inj. 1970 mL

Drug: IN-C006 inj.

RCN301

ACTIVE COMPARATOR

RCN301 1820 mL

Drug: RCN301

Interventions

IN-C006 inj.DRUG

IN-C006 will be injected continuously for 3 days.

Also known as: IN-C006 inj
IN-C006 inj.
RCN301DRUG

RCN301 will be injected continuously for 3 days.

RCN301

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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/㎡

You may not qualify if:

  • Has received parenteral nutrition within 7 days of screening
  • Severe dyslipidemia
  • Uncontrolled diabetes
  • Clinically significant liver disease
  • Clinically significant kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Do Joong PARK

    Seoul National Univerity Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 28, 2022

Study Start

May 4, 2022

Primary Completion

December 9, 2022

Study Completion

December 15, 2022

Last Updated

September 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)