NCT05337228

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 9, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2023

Completed
Last Updated

September 28, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

March 28, 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 (19)

  • Change in nutritional management parameters(Nitrogen balance)

    Day 1 to Day 4

  • Change in nutritional management parameters(Prealbumin)

    Day 1 to Day 4

  • Change in nutritional management parameters(Albumin)

    Day 1 to Day 4

  • Change in nutritional management parameters(Transferrin)

    Day 1 to Day 4

  • Change in inflammation parameters(hs-CRP)

    Day 1 to Day 4

  • +14 more secondary outcomes

Study Arms (2)

IN-C006 Peri inj.

EXPERIMENTAL

IN-C006 Peri inj. 1904 mL

Drug: IN-C006 Peri inj.

RPN301

ACTIVE COMPARATOR

RPN301 2020 mL

Drug: RPN301

Interventions

IN-C006 Peri inj.DRUG

IN-C006 peri inj. will be injected continuously for 3 days.

IN-C006 Peri inj.
RPN301DRUG

RPN301 will be injected continuously for 3 days.

RPN301

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 peripheral 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 28, 2022

First Posted

April 20, 2022

Study Start

August 9, 2022

Primary Completion

February 10, 2023

Study Completion

February 24, 2023

Last Updated

September 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)