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NCT Number: NCT05337228

Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301

This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 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 Peri inj. or RPN301)

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 peripheral 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 Peri inj.

Drug

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

RPN301

Drug

RPN301 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(Nitrogen balance)

    Time frame: Day 1 to Day 4

    Nitrogen balance(Nitrogen intake-Nitrogen out)

  2. Change in nutritional management parameters(Prealbumin)

    Time frame: Day 1 to Day 4

    Prealbumin(mg/L)

  3. Change in nutritional management parameters(Albumin)

    Time frame: Day 1 to Day 4

    Albumin(g/dL)

  4. Change in nutritional management parameters(Transferrin)

    Time frame: Day 1 to Day 4

    Transferrin(mg/dL)

  5. Change in inflammation parameters(hs-CRP)

    Time frame: Day 1 to Day 4

    hs-CRP(mg/L)

  6. Change in inflammation parameters(TNF-α)

    Time frame: Day 1 to Day 4

    TNF-α(pg/mL)

  7. Change in inflammation parameters(IL-6)

    Time frame: Day 1 to Day 4

    IL-6(pg/mL)

  8. Change in fatty acid profile

    Time frame: Day 1 to Day 4

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

  9. 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

  10. Change in laboratory parameters (Hematology)

    Time frame: Day 1 to Day 4

    Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group

    • Hematology

  11. Change in laboratory parameters (Blood chemistry)

    Time frame: Day 1 to Day 4

    Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group

    • Blood chemistry

  12. Change in laboratory parameters (Blood coagulation test)

    Time frame: Day 1 to Day 4

    Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group

    • Blood coagulation test

  13. Change in laboratory parameters (Urinalysis)

    Time frame: Day 1 to Day 4

    Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group

    • Urinalysis

  14. Change in vital sign (Blood pressure)

    Time frame: Day 1 to Day 4

    Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1))

    • Systolic blood pressure(mmHg), Diastolic blood pressure(mmHg)

  15. Change in vital sign (Pulse rate)

    Time frame: Day 1 to Day 4

    Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1))

    • Pulse rate(rate)

  16. Change in vital sign (Body temperature)

    Time frame: Day 1 to Day 4

    Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1))

    • Body temperature(℃)

  17. Change in vital sign (Respiratory rate)

    Time frame: Day 1 to Day 4

    Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1))

    • Respiratory rate(rate)

  18. Normal and abnormal change in physical examination (Frequency)

    Time frame: Day 1 to Day 4

    Frequency of subjects who were normal/clinically insignificant abnormalities before administration of investigational products to clinically significant abnormalities at least once after administration of investigational products

    • 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

  19. Normal and abnormal change in physical examination (Ratio)

    Time frame: Day 1 to Day 4

    Ratio of subjects who were normal/clinically insignificant abnormalities before administration of investigational products to clinically significant abnormalities at least once after administration of investigational products

    • 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 Peri Inj. Compared With RPN301 in Postoperative Patients Requiring Peripheral Parenteral Nutrition

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 20, 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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