Parenteral NutritionPhase 3NCT05299099
Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Inj. Compared With RCN301
A Phase 3 study testing IN-C006 inj. and RCN301 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 inj. and RCN301 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 inj. and RCN301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 May 2022to 15 Dec 2022
- 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 central 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 Inj. Compared With RCN301 in Postoperative Patients Requiring Central Parenteral Nutrition
This study is designed to evaluate the safety and efficacy of IN-C006 inj. and RCN301 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 inj. or RCN301)
- Conditions
- Parenteral Nutrition
- Being tested
- IN-C006 inj., RCN301
- 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 inj.Drug
Also called IN-C006 inj
IN-C006 will be injected continuously for 3 days.
RCN301Drug
RCN301 will be injected continuously for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| IN-C006 inj. | Experimental | IN-C006 inj. 1970 mL Receives: Drug: IN-C006 inj. |
| RCN301 | Active comparator | RCN301 1820 mL Receives: Drug: RCN301 |
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 (7)
Change in nutritional management parameters
Nitrogen balance(Nitrogen intake-Nitrogen out), Prealbumin(mg/L), Albumin(g/dL), Transferrin(mg/dL)
Measured: Day 1 to Day 4
Change in inflammation parameters
hs-CRP(mg/L), TNF-α(pg/mL), 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, Blood chemistry, Blood coagulation test, Urinalysis
Measured: Day 1 to Day 4
Change in vital sign
Blood pressure(mmHg), pulse rate(rate), body temperature(℃) and respiratory rate(rate)
Measured: Day 1 to Day 4
Normal and abnormal change in physical examination
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 posted28 Mar 2022
- Study start4 May 2022
- Primary completion9 Dec 2022
- Study completion15 Dec 2022
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
- 60 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
- NCT05299099
- Sponsor's protocol ID
- IN_CPN_301
- Status last verified
- Feb 2023
- First submitted
- 2 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 Inj. Compared With RCN301 in Postoperative Patients Requiring Central Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT05299099
- Acronym / sponsor ID
- IN_CPN_301
- Conditions
- Parenteral Nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 May 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 28 Mar 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 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)
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 inj. | Experimental | Drug: IN-C006 inj.IN-C006 inj. 1970 mL |
| RCN301 | Active comparator | Drug: RCN301RCN301 1820 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 central 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 inj.Also: IN-C006 injIN-C006 will be injected continuously for 3 days. | Drug | IN-C006 inj. |
| RCN301RCN301 will be injected continuously for 3 days. | Drug | RCN301 |
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
7 secondary outcomes
Change in nutritional management parameters
Time frame: Day 1 to Day 4
Change in inflammation parameters
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
Time frame: Day 1 to Day 4
Change in vital sign
Time frame: Day 1 to Day 4
Normal and abnormal change in physical examination
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 inj. and RCN301 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.