ParentPhase 3OMEGANCT01533298
A Safety, Efficacy Study of CombiflexOmega Peri Versus SmofKabiven Peripheral in Patients With Parenteral Nutrition
A Phase 3 study testing CombiflexOmega peri and SmofKabiven peripheral in people with Parent, run by JW Life Science at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the safety and efficacy of CombiflexOmega peri in comparison to SmofKabiven peripheral in postoperative patients requiring parenteral nutrition. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parent
- What is being tested?
- CombiflexOmega peri and SmofKabiven peripheral
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Jan 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 and older
- Patients are expected to require PN for more than 3 days
- Patients who voluntarily signed the consent form
Who cannot join
- Patients are expected difficult to survive more than 3 days
- Pregnant or breast-feeding women
- BMI > 30 kg/m2
- Patients with severe blood coagulation disorders
- Patients with congenital amino acid metabolism disorders
- Patients with acute shock
Show all 23Show fewer
- Patients with uncontrollable diabetes mellitus
- Patients with hemophage syndrome
- Patients with hypopotassemia (K < 3.0mEq/L)
- Patients having the history of myocardial infarction
- Patients reported the following laboratory value
- fasting TG > 250mg/dl, TC > 300mg/dl
- ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas)
- Creatinine ≥1.5mg/dl
- Ca > 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L
- Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
- Patients having the history of drug or alcohol abuse
- General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, cardiac decompensation
- Patients are in unstable conditions
- Patients with difficult peripheral intravenous
- Patients with parenteral nutrition within 7 days prior to start of the trial
- Participation in another clinical study with an investigational drug or an investigational medical device within 28 days prior to start of study
- Patients judged to be unsuitable for this trial by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open, Multicenter, Compared Phase III Trial to Evaluate the Safety, Efficacy of CombiflexOmega Peri and SmofKabiven Peripheral in Postoperative Patients Requiring Parenteral Nutrition
The purpose of this study is to compare the safety and efficacy of CombiflexOmega peri in comparison to SmofKabiven peripheral in postoperative patients requiring parenteral nutrition.
- Conditions
- Parent
- Being tested
- CombiflexOmega peri, SmofKabiven peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CombiflexOmega periDrug
intravenously over 3 days infusion
SmofKabiven peripheralDrug
intravenously over 3 days infusion
| Study group | Role | What they receive |
|---|---|---|
| CombiflexOmega peri | Experimental | Not described Receives: Drug: CombiflexOmega peri |
| SmofKabiven peripheral | Active comparator | Not described Receives: Drug: SmofKabiven peripheral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of adverse drug reaction
Measured: 4days
Secondary outcomes (2)
Changes of laboratory parameters (biochemistry, hematology, coagulation)
Measured: 5days
Changes of vital signs
Measured: 5days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Life Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533298
- Sponsor's protocol ID
- CW-CFO-301
- Acronym
- OMEGA
- Status last verified
- Feb 2013
- First submitted
- 18 Jan 2012
- Last updated
- 18 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Multicenter, Compared Phase III Trial to Evaluate the Safety, Efficacy of CombiflexOmega Peri and SmofKabiven Peripheral in Postoperative Patients Requiring Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT01533298
- Acronym / sponsor ID
- OMEGA / CW-CFO-301
- Conditions
- Parent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- JW Life ScienceIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Feb 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 purpose of this study is to compare the safety and efficacy of CombiflexOmega peri in comparison to SmofKabiven peripheral in postoperative patients requiring parenteral nutrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CombiflexOmega peri | Experimental | Drug: CombiflexOmega peri |
| SmofKabiven peripheral | Active comparator | Drug: SmofKabiven peripheral |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 20 and older
- Patients are expected to require PN for more than 3 days
- Patients who voluntarily signed the consent form
Key exclusion criteria (23 listed)
- Patients are expected difficult to survive more than 3 days
- Pregnant or breast-feeding women
- BMI > 30 kg/m2
- Patients with severe blood coagulation disorders
- Patients with congenital amino acid metabolism disorders
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 |
|---|---|---|
| CombiflexOmega periintravenously over 3 days infusion | Drug | CombiflexOmega peri |
| SmofKabiven peripheralintravenously over 3 days infusion | Drug | SmofKabiven peripheral |
Primary outcome
Comparison of adverse drug reaction
Time frame: 4days
2 secondary outcomes
Changes of laboratory parameters (biochemistry, hematology, coagulation)
Time frame: 5days
Changes of vital signs
Time frame: 5days
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 18 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.
The record lists no contact. Use the official record to reach the sponsor.
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 CombiflexOmega peri and SmofKabiven peripheral in people with Parent, run by JW Life Science 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 23 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 18 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 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?
Comparison of adverse drug reaction (time frame: 4days). 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 18 Feb 2013.