Parenteral NutritionPhase 3NCT00451646
Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
A Phase 3 study testing SMOF lipid and Intralipid in people with Parenteral Nutrition, run by Fresenius Kabi at 12 sites in 7 countries.
Trial summary
The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parenteral Nutrition
- What is being tested?
- SMOF lipid and Intralipid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesin 7 countries
- Study dates
- Oct 2007to Nov 2008
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In- and out-patients in need of parenteral nutrition due to inability to sustain an adequate oral/enteral food intake for at least 4 weeks
- Written consent from the subject
Who cannot join
- Known hypersensitivity to fish-, egg-, soy-, or peanut-protein or to any of the active substances or excipients
- Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia
- Severe liver insufficiency
- Severe blood coagulation disorders
- Subjects with chronic stable renal insufficiency defined as S-creatinine value of > 25 mg/l (200 µmol/l) or receiving dialysis/hemofiltration therapy
- General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration
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- Unstable conditions
- Unstable angina pectoris
- Acute shock
- Chemotherapy within 4 weeks before start of the trial
- Chemotherapy during the trial
- Subjects for whom the trial treatment is not appropriate
- Female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum pregnancy test and must agree to maintain adequate birth control practice during the study.
- Participation in another clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during the study
- Prior inclusion in the present study
- Any other feature that in the opinion of the investigator should preclude study participation
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
Australia2 sites
Monash Medical Centre
Melbourne, Victoria, 3168
North Shore Private Hospital
Saint Leonards, New South Wales, 2065
Denmark2 sites
Aalborg University Hospital, Department of Medical Gastroenterology
Aalborg, 0 9000
Rigshospitalet, Department of Medical Gastroenterology
Copenhagen, 0 2100
France2 sites
Hopital Beaujon
Clichy, 92110
Hopital Edouard Herriot, Unite de Nutrition a Domicile Lyon
Lyon, 69437
Poland2 sites
Wydzial Lekarski I Katedra Chirurgii Ogolnej
Krakow, 31-501
Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
Warsaw, 00-416
United Kingdom2 sites
Hope Hospital
Manchester, 0M6 8HD
University Hospital, Queen's Medical Centre
Nottingham, NG7 2UH
Israel1 site
Beilinson Medical Center, Department of Surgery "B"
Petah Tikva, 0 45100
About this study
Official title: A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.
- Conditions
- Parenteral Nutrition
- Being tested
- SMOF lipid and Intralipid
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOF lipid and IntralipidDrug
1-2 g, 5-7 days, 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SMOFlipid Receives: Drug: SMOF lipid and Intralipid |
| 2 | Active comparator | Intralipid Receives: Drug: SMOF lipid and Intralipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SMOFlipid 20% assessed by laboratory and clinical parameters (biochemistry, hematology, coagulation), vital signs, adverse events (AEs) as well as inflammation and lipid peroxidation variables
Measured: day 0, week 2, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionNov 2008
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jon Shaffer, MD, Principal investigator, Hope Hospital, Manchester, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451646
- Sponsor's protocol ID
- 05-SMOF-006
- Status last verified
- Oct 2008
- First submitted
- 22 Mar 2007
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT00451646
- Acronym / sponsor ID
- 05-SMOF-006
- Conditions
- Parenteral Nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 23 Mar 2007 (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 aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SMOF lipid and IntralipidSMOFlipid |
| 2 | Active comparator | Drug: SMOF lipid and IntralipidIntralipid |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In- and out-patients in need of parenteral nutrition due to inability to sustain an adequate oral/enteral food intake for at least 4 weeks
- Written consent from the subject
Key exclusion criteria (16 listed)
- Known hypersensitivity to fish-, egg-, soy-, or peanut-protein or to any of the active substances or excipients
- Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia
- Severe liver insufficiency
- Severe blood coagulation disorders
- Subjects with chronic stable renal insufficiency defined as S-creatinine value of > 25 mg/l (200 µmol/l) or receiving dialysis/hemofiltration therapy
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 |
|---|---|---|
| SMOF lipid and Intralipid1-2 g, 5-7 days, 28 days | Drug | 1, 2 |
Primary outcome
Safety and tolerability of SMOFlipid 20% assessed by laboratory and clinical parameters (biochemistry, hematology, coagulation), vital signs, adverse events (AEs) as well as inflammation and lipid peroxidation variables
Time frame: day 0, week 2, week 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 27 Aug 2010.
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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.
Jon Shaffer, MD principal investigator
Hope Hospital, Manchester, United Kingdom
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SMOF lipid and Intralipid in people with Parenteral Nutrition, run by Fresenius Kabi at 12 sites in 7 countries.
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 2 inclusion and 16 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 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, Denmark, France, Poland, United Kingdom and 2 more countries. 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?
Safety and tolerability of SMOFlipid 20% assessed by laboratory and clinical parameters (biochemistry, hematology, coagulation), vital signs, adverse events (AEs) as well as inflammation and lipid peroxidation variables (time frame: day 0, week 2, week 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 27 Aug 2010.