Nutrition SupportPhase 3NCT01579097
Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-chamber Parenteral Nutrition Formulation
A Phase 3 study testing Oliclinomel N4 and Compounded ternary parenteral nutrition admixtures in people with Nutrition Support, run by Baxter Healthcare Corporation at 1 site in China.
Trial summary
The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or contraindicated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutrition Support
- What is being tested?
- Oliclinomel N4 and Compounded ternary parenteral nutrition admixtures
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Jan 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient but hospitalized < 14 days prior to enrollment
- Requires PN because oral or enteral nutrition is not possible, insufficient, or contraindicated
- Has capability to complete at least 5 days of study treatment (i.e., PN)
- Has a useable peripheral vein for delivery of intravenous (IV) PN
Who cannot join
- Has a life expectancy of < 6 days from initiation of study treatment, in the opinion of the Investigator
- Known hypersensitivity to the components of either of the investigational study treatments
- Use of prohibited medications (e.g. glucocorticosteroids or antitumor chemotherapeutic agents) within 30 days prior to enrollment
- Known serious clinically significant condition that would preclude participation in the study
- Known chronic active hepatitis, elevated liver function tests
- Known history of human immunodeficiency virus infection
- Known severe dyslipidemia, severe hyperglycemia,clinically significant abnormalities of plasma electrolytes
- Known pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-Chamber Parenteral Nutrition Formulation (Oliclinomel N4)
The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or contraindicated.
- Conditions
- Nutrition Support
- Being tested
- Oliclinomel N4, Compounded ternary parenteral nutrition admixtures
- Keywords
- (PN) Parenteral nutrition, oral/enteral not possible
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oliclinomel N4Other
Also called Oliclinomel N4-550
Oliclinomel is a PN product which provides the macronutrients (e.g., dextrose, amino acids, and lipids) for patients when oral or enteral nutrition is not possible, insufficient, or contraindicated
Compounded ternary parenteral nutrition admixturesOther
Study treatment will be administered for a minimum of 5 days up to a maximum of 14 days
| Study group | Role | What they receive |
|---|---|---|
| compounded ternary parenteral nutrition | Active comparator | compounded ternary Parenteral Nutrition admixture Receives: Other: Compounded ternary parenteral nutrition admixtures |
| Oliclinomel N4 formulation | Experimental | Oliclinomel N4 is a ready-to-use PN product presented as a triple chamber bag Receives: Other: Oliclinomel N4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Prealbumin
Measured: Serum Prealbumin at Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionNov 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition SupportStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baxter Investigative Site, Study director, Shanghai, ChinaBaxter Investigative Site, Study director, Shantou, ChinaBaxter Investigative Site, Study director, Haikou, ChinaBaxter Investigative Site, Study director, Jiangsu Province, ChinaBaxter Investigative Site, Study director, Beijing, ChinaBaxter Investigative Site, Study director, Changsha, ChinaBaxter Investigative Site, Study director, Hangzhou, ChinaBaxter Investigative Site, Study director, Nanning, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579097
- Sponsor's protocol ID
- CSPIVTCHN001
- Status last verified
- Jan 2013
- First submitted
- 13 Apr 2012
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-Chamber Parenteral Nutrition Formulation (Oliclinomel N4)
- ClinicalTrials.gov ID
- NCT01579097
- Acronym / sponsor ID
- CSPIVTCHN001
- Conditions
- Nutrition Support
- Keywords
- (PN) Parenteral nutrition, oral/enteral not possible
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Apr 2012 (estimated)
- 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.
The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or contraindicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| compounded ternary parenteral nutrition | Active comparator | Other: Compounded ternary parenteral nutrition admixturescompounded ternary Parenteral Nutrition admixture |
| Oliclinomel N4 formulation | Experimental | Other: Oliclinomel N4Oliclinomel N4 is a ready-to-use PN product presented as a triple chamber bag |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatient but hospitalized < 14 days prior to enrollment
- Requires PN because oral or enteral nutrition is not possible, insufficient, or contraindicated
- Has capability to complete at least 5 days of study treatment (i.e., PN)
- Has a useable peripheral vein for delivery of intravenous (IV) PN
Key exclusion criteria (8 listed)
- Has a life expectancy of < 6 days from initiation of study treatment, in the opinion of the Investigator
- Known hypersensitivity to the components of either of the investigational study treatments
- Use of prohibited medications (e.g. glucocorticosteroids or antitumor chemotherapeutic agents) within 30 days prior to enrollment
- Known serious clinically significant condition that would preclude participation in the study
- Known chronic active hepatitis, elevated liver function tests
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 |
|---|---|---|
| Oliclinomel N4Also: Oliclinomel N4-550Oliclinomel is a PN product which provides the macronutrients (e.g., dextrose, amino acids, and lipids) for patients when oral or enteral nutrition is not possible, insufficient, or contraindicated | Other | Oliclinomel N4 formulation |
| Compounded ternary parenteral nutrition admixturesStudy treatment will be administered for a minimum of 5 days up to a maximum of 14 days | Other | compounded ternary parenteral nutrition |
Primary outcome
Serum Prealbumin
Time frame: Serum Prealbumin at Day 5
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 1 Feb 2013.
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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.
Baxter Investigative Site study director
Shanghai, China
Baxter Investigative Site study director
Shantou, China
Baxter Investigative Site study director
Haikou, China
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 Oliclinomel N4 and Compounded ternary parenteral nutrition admixtures in people with Nutrition Support, run by Baxter Healthcare Corporation at 1 site in China.
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 4 inclusion and 8 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 1 Feb 2013. 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 China. 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?
Serum Prealbumin (time frame: Serum Prealbumin at Day 5). 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 1 Feb 2013.