Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00451646




Registration number
NCT00451646
Ethics application status
Date submitted
22/03/2007
Date registered
23/03/2007
Date last updated
27/08/2010

Titles & IDs
Public title
Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Scientific title
A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Secondary ID [1] 0 0
05-SMOF-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenteral Nutrition 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SMOF lipid and Intralipid

Experimental: 1 - SMOFlipid

Active comparator: 2 - Intralipid


Treatment: Drugs: SMOF lipid and Intralipid
1-2 g, 5-7 days, 28 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
day 0, week 2, week 4

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
North Shore Private Hospital - Saint Leonards
Recruitment hospital [2] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aalborg
Country [2] 0 0
Denmark
State/province [2] 0 0
Copenhagen
Country [3] 0 0
France
State/province [3] 0 0
Clichy la Garenne
Country [4] 0 0
France
State/province [4] 0 0
Lyon
Country [5] 0 0
Israel
State/province [5] 0 0
Petah Tiqwa
Country [6] 0 0
Netherlands
State/province [6] 0 0
Nijmegen
Country [7] 0 0
Poland
State/province [7] 0 0
Krakow
Country [8] 0 0
Poland
State/province [8] 0 0
Warsaw
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Manchester
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fresenius Kabi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jon Shaffer, MD
Address 0 0
Hope Hospital, Manchester, United Kingdom
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00451646