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    The EU Clinical Trials Register currently displays   35510   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-006165-18
    Sponsor's Protocol Code Number:FEN
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-02-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-006165-18
    A.3Full title of the trial
    A randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects
    Een gerandomiseerde dubbelblinde placebogecontroleerde studie naar het effect van fenretinide Lym-X-Sorb op insulinegevoeligheid in obese insulineresistente proefpersonen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of fenretinide on insulin sensitivity
    Het effect van fenretinide op insulinegevoeligheid
    A.3.2Name or abbreviated title of the trial where available
    The effects of fenretinide on insulin sensitivity
    Het effect van fenretinide op insulinegevoeligheid
    A.4.1Sponsor's protocol code numberFEN
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAcademic Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointMireille Serlie
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205666071
    B.5.5Fax number0031206917682
    B.5.6E-mailm.j.serlie@amc.uva.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namefenretinide/Lym-X-Sorb
    D.3.2Product code HPR/LXS
    D.3.4Pharmaceutical form Oral powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFENRETINIDE
    D.3.9.1CAS number 65646-68-6
    D.3.9.4EV Substance CodeSUB07595MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number308
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral powder
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obesity
    Metabolic syndrome X
    Insulin resistance
    Fatty liver
    Obesitas
    Metabool syndroom
    Insulineresistentie
    Leversteatose
    E.1.1.1Medical condition in easily understood language
    Obesity
    Insulin resistance
    Fatty liver disease
    Ernstig overgewicht
    Insulineongevoeligheid
    Leververvetting
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjects
    Vaststellen van het effect van fenretinide op hepatische en perifere insulinegevoeligheid in obese, insulineresistente proefpersonen
    E.2.2Secondary objectives of the trial
    To assess the effects of fenretinide on hepatic steatosis, body weight and body fat composition
    Vaststellen van het effect van fenretinide op leversteatose, lichaamsgewicht en lichaamsvetcompositie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-65 years
    BMI ≥ 30 kg • m-2
    HOMA-IR ≥ 2.7
    Signed informed consent
    Leeftijd tussen 18-65 jaar
    BMI ≥ 30 kg • m-2
    HOMA-IR ≥ 2.7
    Getekend informed consent
    E.4Principal exclusion criteria
    T2DM treated with medication other than metformin or sulfonylurea derivates
    Any medical condition except for glucose intolerance, T2DM, hypertension and secondary dyslipidemia
    Retinol levels of < 1.8 uM
    Pregnant, lactating or planning pregnancy during the treatment
    Diabetes mellitus type 2 (DM2) behandeld met medicatie anders dan metformine of sulfonylureumderivaten
    Alle medische condities behoudens glucoseintolerantie, DM2, hypertensie en secundaire dyslipidemie
    Retinolconcentratie < 1.8 uM
    Zwanger, lacterend of zwangerschapswens tijdens de studie
    E.5 End points
    E.5.1Primary end point(s)
    Changes in hepatic and peripheral insulin sensitivity
    Veranderingen in hepatische en perifere insulinegevoeligheid
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and day 88 of treatment
    Baseline en dag 88 van behandeling
    E.5.2Secondary end point(s)
    Liver steatosis
    Plasma retinol and RBP4 levels
    Plasma HPR and its metabolites (MPR, 4-oxo-HPR) levels
    Resting energy expenditure (REE) and body fat composition
    Glucoregulatory hormones, adipokines and markers of inflammation
    Safety and tolerability of HPR/LXS
    Leversteatose
    Retinol- en RBP4-waarden
    HPR- en zijn metabolieten (MPR, 4-oxo-HPR)-waarden
    Energieverbruik in rust (REE) en lichaamsvetcompositie
    Glucoregulerende hormonen, adipokines en inflammatiemarkers
    Veiligheid en tolerabiliteit van HPR/LXS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, days 7, 28, 58 and 88 of treatment; 14 days after last drug administration
    Baseline, dag 7, 28, 58 en 88 van behandeling; 14 dagen na laatste inname
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Laatste visite laatste proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    N/A
    Nvt
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-20
    P. End of Trial
    P.End of Trial StatusOngoing
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