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    Summary
    EudraCT Number:2015-000887-32
    Sponsor's Protocol Code Number:ORN-02
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-05-11
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-000887-32
    A.3Full title of the trial
    Prophylactic treatment of osteoradionecrosis (ORN) with pentoxifylline and α-tocopherol (PENTO)
    Profylaktisk behandling av osteoradionekros (ORN) med pentoxifyllin och α-tokoferol (PENTO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prophylaxis with PENTO before tooth extraction
    Profylax med PENTO före tandextraktion
    A.4.1Sponsor's protocol code numberORN-02
    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 SponsorVästra Götalandsregionen/NÄL
    B.1.3.4CountrySweden
    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 supportVästra Götalandsregionen
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVästra Götalandsregionen/NÄL
    B.5.2Functional name of contact pointKäkkirurgiska kliniken
    B.5.3 Address:
    B.5.3.1Street AddressLärketorpsvägen
    B.5.3.2Town/ cityTrollhättan
    B.5.3.3Post code416 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+46(0)70 289 59 59
    B.5.6E-mailjosephine.skoldestam@vgregion.se
    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 Yes
    D.2.1.1.1Trade name Trental
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationLatvia
    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 nameTrental (pentoxyfylline)
    D.3.2Product code NDC: 0039-0078-10
    D.3.4Pharmaceutical form Tablet
    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 INNPENTOXIFYLLINE
    D.3.9.1CAS number 6493-05-6
    D.3.9.4EV Substance CodeSUB09705MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Tokoferol
    D.2.1.1.2Name of the Marketing Authorisation holderMeda AB, Box 906, 170 09 Solna
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameTokoferol (Vitamin E)
    D.3.2Product code NPU26649
    D.3.4Pharmaceutical form Capsule
    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.3.9.1CAS number 9002-96-44
    D.3.9.3Other descriptive nameVITAMIN E TPGS (D-A-TOCOPHERYL POLYETHYLENE GLYCO 1000)
    D.3.9.4EV Substance CodeSUB31955
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoradionecrosis
    Osteoradionekros
    E.1.1.1Medical condition in easily understood language
    Osteonecrosis after radiation
    Benvävnadsdöd efter strålbehandling
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10031264
    E.1.2Term Osteonecrosis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10067352
    E.1.2Term Osteoradionecrosis
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is to evaluate tissue and bone healing in the short and long term
    Primärt syfte är att utvärdera mjuk- och benvävnadsläkning på kort och på lång sikt
    E.2.2Secondary objectives of the trial
    To evaluated the treatment effect on pain and infection, jaw opening capasity, saliva secretion, quality of life and the genotype and gene expression
    Sekundärt utvärderas behandlingenseffekt på smärta och infektion, gapförmåga, salivsekretion, livskvalité samt genotyp och genutryck
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Tissue-scale (SH) index S0H2-3 or S1H1-3
    • Men and women aged ≥18 years
    • Understand the Swedish speaking and writing
    •Tissue-scale (SH-index) S0H2-3 eller S1H1-3
    •Män och kvinnor i ålder ≥18 år
    •Förstå svenska tal och skrift
    E.4Principal exclusion criteria
    •Läkemedelsinteraktioner med studiemedicinen
    •Oförmåga att svälja tabletter
    •Deltagande i annan samtidigt pågående studie av ORN
    •Alkohol- eller drogmissbruk
    •Psykisk sjukdom eller andra tillstånd som läkaren/tandläkaren bedömer som oförenlig med studieprotokollet
    E.5 End points
    E.5.1Primary end point(s)
    Status evaluated according Tissue-scale,i.e. extent of bone lesion
    measured in mm. Primary endpoint is change in the SH index measured
    with clinical and radiological methods.
    Status utvärderas enligt Tissue-scale, med benblottans utbredning mätt i
    mm. Primär end-point är förändring i SH-index mätt med kliniska och
    röntgenologiska metoder
    E.5.1.1Timepoint(s) of evaluation of this end point
    3, 6 24 months
    3, 6 24 månader
    E.5.2Secondary end point(s)
    •Pain intensity according to VAS scale procedures.
    •Infection measured on a three-point scale
    •Jaw opening measured in millimeters
    •Salivation measured as ml stimulated saliva /min
    •Quality of Life (QLQ C-30, QLQ H & N35)
    •Gene expression in the irradiated tissue and genetic profile
    •Smärtintensitet enligt VAS-skala.
    •Infektion mätt på en tregradig skala
    •Gapförmåga mätt som max gapförmåga i mm, mätt mellan
    framtänderna.
    •Salivutsöndring mätt som ml stimulerad saliv/min
    •Quality of Life (QLQ C-30, QLQ H&N35)
    •Genexpression i den strålade vävnaden och genetisk profil
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 24 months
    3, 6 24 månader
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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.8.5The 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 No
    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
    Sista patientens sista besök
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 state80
    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)
    Sampling and rehabilitation procedures will be followed according to
    routines.
    Patients will returnat 3-months follow up for
    side effects, blood pressure, blood counts, local status, radiology
    and renewed recipes on trial medication
    Provtagnings- och rehabiliteringsrutiner kommer att följas enligt
    rutiner.
    Patienterna återkommer vid 2 tillfällen på 3-månaderskontroller av
    biverkningar, blodtryck, blodstatus, lokalstatus, röntgenundersökning
    och förnyat recept på prövningsmedicin
    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 Decision2015-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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