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Completed

NCT Number: NCT05299099

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

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

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Key information

Conditions

Parenteral Nutrition Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IN-C006 inj.

Drug

IN-C006 will be injected continuously for 3 days.

Other names: IN-C006 inj

RCN301

Drug

RCN301 will be injected continuously for 3 days.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. Change in inflammation parameters

    Time frame: Day 1 to Day 4

    hs-CRP(mg/L), TNF-α(pg/mL), IL-6(pg/mL)

  3. Change in fatty acid profile

    Time frame: Day 1 to Day 4

    LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL)

  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

  5. Change in laboratory parameters

    Time frame: Day 1 to Day 4

    Hematology, Blood chemistry, Blood coagulation test, Urinalysis

  6. Change in vital sign

    Time frame: Day 1 to Day 4

    Blood pressure(mmHg), pulse rate(rate), body temperature(℃) and respiratory rate(rate)

  7. 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

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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