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    Summary
    EudraCT Number:2013-000343-11
    Sponsor's Protocol Code Number:OC005OMBMT
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-04-08
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-000343-11
    A.3Full title of the trial
    Clinical trial with lozenges as local anesthesia for allogeneic bone marrow transplant patients with oral mucositis
    Klinisk forsøg med sugetabletter som lokal smertebehandling til allogen knoglemarvstransplanteret patienter med oral mucositis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial with lozenges as local anesthesia for bone marrow transplant patients with oral pain
    Klinisk forsøg med sugetabletter som lokal smertebehandling til knoglemarvstransplanteret patienter med mundsmerter
    A.3.2Name or abbreviated title of the trial where available
    OMBMT Lozenge
    OMBMT Sugetablet
    A.4.1Sponsor's protocol code numberOC005OMBMT
    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 SponsorClinical Research Centre, Hvidovre University Hospital
    B.1.3.4CountryDenmark
    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 supportOracain II ApS
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Centre, Hvidovre University Hospital
    B.5.2Functional name of contact pointStine Mogensen
    B.5.3 Address:
    B.5.3.1Street AddressKettegaard Allé 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post codeDK-2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538626077
    B.5.5Fax number+4538623797
    B.5.6E-mailsugetablet@gmail.com
    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 nameBupizenge
    D.3.2Product code BUPI25
    D.3.4Pharmaceutical form Lozenge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    Oropharyngeal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBupivacaine Hydrochloride
    D.3.9.1CAS number 2180-92-9
    D.3.9.2Current sponsor codeBUPI25
    D.3.9.3Other descriptive nameBUPIVACAINE HCL
    D.3.9.4EV Substance CodeSUB00902MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboLozenge
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oral pain due to oral mucositis in patients undergoing a bone marrow transplant
    Orale smerter på grund af oral mucositis hos patienter der har gennemgået en knoglemarvstransplantation
    E.1.1.1Medical condition in easily understood language
    Oral pain in patients undergoing a bone marrow transplant
    Mundsmerter hos patienter der har gennemgået en knoglemarvstransplantation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10028130
    E.1.2Term Mucositis oral
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    After administration of bupivacain lozenges the patients pain due to oral mucositis can be reduced, showed on a Visuel Analog Scale (VAS) 0-10, where as 0 = No pain and 10 = worst pain ever
    Nedsætte patienternes oral mucositis smerter, vist ved lavere scoring på den Visuelle Analog Skala (VAS) 0-10, hvor 0 = ingen smerter og 10 = værst tænkelige smerter, efter administration af bupivacain sugetablet.
    E.2.2Secondary objectives of the trial
    - Reduce the use of opioids administered by a Patient Controlles Analgesia (PCA) pump
    - Improve the patients nutrition messuerede by weight and food intake
    - Improve the patients quality og life messuerede by a questionnaire
    - Nedsætte forbruget af opioider administreret vha. PCA pumpe
    - Forbedre patienternes ernæring målt ud fra vægt- og kostregistrering,
    - Forbedre patienternes livskvalitet målt ud spørgeskema.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Scheduled for a bone marrow transplant
    - Age between 18 and 80 years old
    - Ability to speak, read and understand danish
    - Ability to give written and oral consent
    - Skal gennemgå en knoglemarvstransplantation
    - Alder mellem 18 og 80 år
    - I stand til at tale, læse og forstå dansk
    - Skal kunne afgive informeret skriftligt samtykke
    E.4Principal exclusion criteria
    - Known allergy towards bupivacaine or other local analgesia of the amide type
    - Pregnancy
    - Breastfeeding women
    - Kendt allergi overfor bupivacain eller andre lokalanalgetika fra amidgruppen
    - Graviditet
    - Ammende kvinder
    E.5 End points
    E.5.1Primary end point(s)
    VAS evaluation of oral pain when administration of the lozenge
    VAS scoring af orale smerter i forbindelse med administration af sugetablet
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily
    Dagligt
    E.5.2Secondary end point(s)
    - Timepoint for administration of the lozenge
    - Number of lozenges administrated per day
    - Opioid use administrated from a "Patient controlled anesthesia" (PCA) pump
    - Number of failed attempt to get opioids from the PCA pump
    - Weightloss
    - Food intake
    - Tidspunkt for administration af sugetablet
    - Antal sugetabletter administreret pr. dag
    - Morfinforbrug fra PCA pumpe
    - Antal tryk på PCA der ikke udløser morfin
    - Vægt
    - Kostindtag
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily
    Dagligt
    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 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.8.5The 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
    Sidste patient sidste forsøgsdag
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    None
    Ingen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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