Clinical Trial to Evaluate the Safety and Efficacy of IN-... | NCT05299099

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

NCT05299099

Sponsor

HK inno.N Corporation

Status

Completed

Last Update Posted

Sep 28, 2023Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Parenteral Nutrition

Interventions

IN-C006 inj.
RCN301

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2022Actual

Primary Completion Date

Dec 9, 2022Actual

Completion Date

Dec 15, 2022Actual

First Submitted Date

Mar 2, 2022

First Submission Date that Met QC Criteria

Mar 17, 2022

First Posted Date

Mar 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2023

Last Update Posted Date

Sep 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IN-C006 inj.	Experimental	IN-C006 inj. 1970 mL	Drug: IN-C006 inj.
RCN301	Active Comparator	RCN301 1820 mL	Drug: RCN301

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IN-C006 inj.	Drug	IN-C006 will be injected continuously for 3 days.	IN-C006 inj.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Change in inflammation parameters

Other Outcomes

Not provided

Eligibility Module

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 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Do Joong PARK	Seoul National Univerity Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006963	Hyperphagia

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided