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    Summary
    EudraCT Number:2015-000618-23
    Sponsor's Protocol Code Number:ORN-01
    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:2015-03-03
    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 number2015-000618-23
    A.3Full title of the trial
    Treatment of osteoradionecrosis (ORN) with pentoxifylline and α-tocopherol (PENTO)
    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
    Effect of pentoxifylline and vitamin E on osteoradionecrosis
    Effekt av pentoxifyllin och vitamin E på benvävnadsdöd efter strålbehandling
    A.4.1Sponsor's protocol code numberORN-01
    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)702-895959
    B.5.6E-mailjosephine.skoldstam@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 (Pentoxifylline)
    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.3.8INN - Proposed INNE vitamin
    D.3.9.1CAS number 10191-41-0
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNE-vimin
    D.3.9.1CAS number 0010191-41-0
    D.3.9.3Other descriptive nameDL VITAMINE E ACETATE
    D.3.9.4EV Substance CodeSUB127254
    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.IMP: 3
    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 Bonefos
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AB, Box 606, 169 26 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 nameBonefos (klodronat)
    D.3.2Product code PL 00010/0522
    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 INNBonefos
    D.3.9.1CAS number 10596-23-3
    D.3.9.2Current sponsor code11659
    D.3.9.3Other descriptive nameCLODRONIC ACID
    D.3.9.4EV Substance CodeSUB06693MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1600
    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
    Osteoradionecrosis
    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 (2 years )
    Primärt syfte är att utvärdera mjuk- och benvävnadsläkning på kort och på lång sikt (2 år).
    Primär end-point är förändring i SH-index mätt med kliniska och röntenologiska metoder.
    E.2.2Secondary objectives of the trial
    •Pain intensity
    •Infection
    •Jaw opening
    •Salivation
    •Hearing
    •Quality of Life
    •Gene expression and genetic profile
    •Smärtintensitet
    •Infektion
    •Gapförmåga
    •Salivutsöndring
    •Hörsel
    •Quality of Life
    •Genexpression och genetisk profil
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Tumor-free, prior radiation in head and neck region
    •Tissue-scale (SH index) S0H2-3 or S1H1-3
    •Men and women age ≥18 years
    •Understand the Swedish speaking and writing
    •Tumörfri, tidigare strålbehandling i huvud-halsregionen
    •Tissue-scale (SH-index) S0H2-3 eller S1H1-3
    •Män och kvinnor ålder ≥18 år
    •Förstå svenska tal och skrift
    E.4Principal exclusion criteria
    •Drug interactions with study medication
    •Inability to swallow tablets
    •Participation in a simultaneous and similar study
    •Alcohol or drug abuse
    •Mental illness or other conditions that the doctor/dentist deems incompatible with the study protocol
    •Läkemedelsinteraktioner med studiemedicinen
    •Oförmåga att svälja tabletter
    •Deltagande i annan samtidig liknande studie
    •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, with 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, 9, 12, 18 and 24 months
    3, 6, 9, 12, 18 och 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
    •Hearing measured in tone mean (dB).
    •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
    •Hörsel mätt i tonmedelvärde (dB).
    •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, 9, 12, 18 and 24 months
    3, 6, 9, 12, 18 och 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 Yes
    E.6.5Efficacy Yes
    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 No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observationsstudie
    Observational study
    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 trial1
    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 patienten 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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 in accordance with procedures. Phone call for monitoring of adverse reactions after 2 weeks. If necessary referral to hospital dentistry for prophylaxis and/or dental care. Patients will thereafter return each 3-months for monitoring of side effects, blood pressure, blood status, local status, radiology and renewed recipes of trial medication
    Provtagnings- och rehabiliteringsrutiner kommer att följas enligt rutiner. Telefonsamtal för kontroll av biverkningar efter 2 veckor. Ev. remiss till till sjukhustandvård för profylax och/eller tandvård. Patienterna återkommer därefter 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 Decision2015-04-30
    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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