Parenteral NutritionPhase 3NCT05337228
Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301
A Phase 3 study testing IN-C006 Peri inj. and RPN301 in people with Parenteral Nutrition, run by HK inno.N Corporation at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Parenteral Nutrition
- What is being tested?
- IN-C006 Peri inj. and RPN301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Aug 2022to 24 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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/㎡
Who cannot join
- Has received parenteral nutrition within 7 days of screening
- Severe dyslipidemia
- Uncontrolled diabetes
- Clinically significant liver disease
- Clinically significant kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 in postoperative patients requiring central parenteral nutrition.
Read the 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 Peri inj. or RPN301)
- Conditions
- Parenteral Nutrition
- Being tested
- IN-C006 Peri inj., RPN301
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-C006 Peri inj.Drug
IN-C006 peri inj. will be injected continuously for 3 days.
RPN301Drug
RPN301 will be injected continuously for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| IN-C006 Peri inj. | Experimental | IN-C006 Peri inj. 1904 mL Receives: Drug: IN-C006 Peri inj. |
| RPN301 | Active comparator | RPN301 2020 mL Receives: Drug: RPN301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse drug reaction rate
Rate of treatment-related adverse events as assessed by CTCAE v5.0 and investigator's evaluation
Measured: Day 1 to Day 4
Secondary outcomes (19)
Change in nutritional management parameters(Nitrogen balance)
Nitrogen balance(Nitrogen intake-Nitrogen out)
Measured: Day 1 to Day 4
Change in nutritional management parameters(Prealbumin)
Prealbumin(mg/L)
Measured: Day 1 to Day 4
Change in nutritional management parameters(Albumin)
Albumin(g/dL)
Measured: Day 1 to Day 4
Change in nutritional management parameters(Transferrin)
Transferrin(mg/dL)
Measured: Day 1 to Day 4
Change in inflammation parameters(hs-CRP)
hs-CRP(mg/L)
Measured: Day 1 to Day 4
Change in inflammation parameters(TNF-α)
TNF-α(pg/mL)
Measured: Day 1 to Day 4
Change in inflammation parameters(IL-6)
IL-6(pg/mL)
Measured: Day 1 to Day 4
Change in fatty acid profile
LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL)
Measured: Day 1 to Day 4
Incidence of Adverse event
Rate of adverse events as assessed by CTCAE v5.0 and investigator's evaluation
Measured: Day 1 to Day 4
Change in laboratory parameters (Hematology)
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
Measured: Day 1 to Day 4
Change in laboratory parameters (Blood chemistry)
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
Measured: Day 1 to Day 4
Change in laboratory parameters (Blood coagulation test)
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
Measured: Day 1 to Day 4
Change in laboratory parameters (Urinalysis)
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
Measured: Day 1 to Day 4
Change in vital sign (Blood pressure)
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)
Measured: Day 1 to Day 4
Change in vital sign (Pulse rate)
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)
Measured: Day 1 to Day 4
Change in vital sign (Body temperature)
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(℃)
Measured: Day 1 to Day 4
Change in vital sign (Respiratory rate)
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)
Measured: Day 1 to Day 4
Normal and abnormal change in physical examination (Frequency)
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
Measured: Day 1 to Day 4
Normal and abnormal change in physical examination (Ratio)
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
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start9 Aug 2022
- Primary completion10 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Do Joong PARK, Study chair, Seoul National Univerity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337228
- Sponsor's protocol ID
- IN_PPN_301
- Status last verified
- Feb 2023
- First submitted
- 28 Mar 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05337228
- Acronym / sponsor ID
- IN_PPN_301
- Conditions
- Parenteral Nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 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 Peri inj. or RPN301)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IN-C006 Peri inj. | Experimental | Drug: IN-C006 Peri inj.IN-C006 Peri inj. 1904 mL |
| RPN301 | Active comparator | Drug: RPN301RPN301 2020 mL |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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/㎡
Key exclusion criteria (5 listed)
- Has received parenteral nutrition within 7 days of screening
- Severe dyslipidemia
- Uncontrolled diabetes
- Clinically significant liver disease
- Clinically significant kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN-C006 Peri inj.IN-C006 peri inj. will be injected continuously for 3 days. | Drug | IN-C006 Peri inj. |
| RPN301RPN301 will be injected continuously for 3 days. | Drug | RPN301 |
Primary outcome
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
19 secondary outcomes
Change in nutritional management parameters(Nitrogen balance)
Time frame: Day 1 to Day 4
Change in nutritional management parameters(Prealbumin)
Time frame: Day 1 to Day 4
Change in nutritional management parameters(Albumin)
Time frame: Day 1 to Day 4
Change in nutritional management parameters(Transferrin)
Time frame: Day 1 to Day 4
Change in inflammation parameters(hs-CRP)
Time frame: Day 1 to Day 4
Change in inflammation parameters(TNF-α)
Time frame: Day 1 to Day 4
Change in inflammation parameters(IL-6)
Time frame: Day 1 to Day 4
Change in fatty acid profile
Time frame: Day 1 to Day 4
Incidence of Adverse event
Time frame: Day 1 to Day 4
Change in laboratory parameters (Hematology)
Time frame: Day 1 to Day 4
Change in laboratory parameters (Blood chemistry)
Time frame: Day 1 to Day 4
Change in laboratory parameters (Blood coagulation test)
Time frame: Day 1 to Day 4
Change in laboratory parameters (Urinalysis)
Time frame: Day 1 to Day 4
Change in vital sign (Blood pressure)
Time frame: Day 1 to Day 4
Change in vital sign (Pulse rate)
Time frame: Day 1 to Day 4
Change in vital sign (Body temperature)
Time frame: Day 1 to Day 4
Change in vital sign (Respiratory rate)
Time frame: Day 1 to Day 4
Normal and abnormal change in physical examination (Frequency)
Time frame: Day 1 to Day 4
Normal and abnormal change in physical examination (Ratio)
Time frame: Day 1 to Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Do Joong PARK study chair
Seoul National Univerity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IN-C006 Peri inj. and RPN301 in people with Parenteral Nutrition, run by HK inno.N Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse drug reaction rate (time frame: Day 1 to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.