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    Summary
    EudraCT Number:2014-002346-42
    Sponsor's Protocol Code Number:P2HNC01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-14
    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 number2014-002346-42
    A.3Full title of the trial
    Clinical trial with lozenges as local pain treatment for head and neck cancer patients with oral mucostis
    Klinisk forsøg med sugetabletter som lokal smertebehandling til hoved/hals cancer
    patienter med oral mucositis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial with lozenges as local pain treatment for head and neck cancer patients with oral inflammation
    Forsøg med sugetabletter som lokal smertebehandling til hoved/hals kræft patienter med mundbetændelse
    A.4.1Sponsor's protocol code numberP2HNC01
    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 SponsorCopenhagen University Hospital, Hvidovre
    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 supportPCG Clinical Services AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCopenhagen University Hospital, Hvidovre
    B.5.2Functional name of contact pointStine Mogensen
    B.5.3 Address:
    B.5.3.1Street AddressKettegaard Alle 30
    B.5.3.2Town/ cityHvidore
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538626077
    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
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBupivacaine
    D.3.9.1CAS number 38396-39-3
    D.3.9.2Current sponsor codeBUPI25
    D.3.9.3Other descriptive nameBUPIVACAINE HYDROCHLORIDE
    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
    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 head and neck cancer patients which are undergoing radiation therapy
    Orale smerter som følge af oral mucositis hos hoved/halscancer patienter i stråleterapi
    E.1.1.1Medical condition in easily understood language
    Oral pain due to oral inflammation in head and neck cancer patients which are undergoing radiation therapy
    Mundsmerter på grund af betændelse i munden hos hoved/hals kræft patienter i strålebehandling
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10028130
    E.1.2Term Mucositis oral
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10037763
    E.1.2Term Radiation mucositis
    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
    To investigate if bupivacaine lozenges are an effective and patient friendly pain treatment for oral pain in head and neck cancer patients with oral mucositis and thereby reduce the need for opioids as pain treatment in this patient group compared to standard pain treatment.
    Undersøge om bupivacainsugetabletter er en effektiv og patientvenlig smertebehandling mod mundsmerter for hoved/hals cancer patienter med oral mucositis.
    E.2.2Secondary objectives of the trial
    Reduction of the use of opioids as additional pain treatment in the lozenge group compared to standard treatment group
    Reduktion i forbruget af opioider som yderligere smertebehandling i sugetabletgruppen sammenlignet med standardbehandlingsgruppen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosed with head and neck cancer and scheduled for radiation therapy
    - Age between 18 and 80
    - Be able to speak, read and understand danish
    - Be able to give informed written consent
    - Be able to use an electronic media with a touch screen, such as a smart phone or a tablet PC
    Diagnosticeret med hoved/hals cancer og have planlagt strålebehandling
    - Alder mellem 18 og 80 år
    - I stand til at tale, læse og forstå dansk
    - Skal kunne afgive informeret skriftligt samtykke
    - I stand til at et bruge elektronisk medie med touch screen, så som smartphone og tablet PC.
    E.4Principal exclusion criteria
    - Known allergy to bupivacaine or other local analgesia of the amid type
    - Pregnancy
    - Breast feeding women
    - Use of opioid pain treatment before start of radiation treatment
    - Kendt allergi overfor bupivacain eller andre lokalanalgetika fra amidgruppen
    - Graviditet
    - Ammende kvinder
    - Behov for smertebehandling med morfin før strålebehandlingen start.
    E.5 End points
    E.5.1Primary end point(s)
    Measurement of the oral pain on a visual analogue scale from 0-100 mm, where 0 = no pain and 100 = worst thinkable oral pain
    Patienternes orale mucositis smerter, vist ved scoring på den Visuelle Analog Skala (VAS) 0-100 mm, hvor 0 = ingen smerter og 100 = værst tænkelige mundsmerter
    E.5.1.1Timepoint(s) of evaluation of this end point
    The patient has to measure VAS before administration of each bupivacaine lozenge and 60 minutes after. In the control group will VAS be measured every 2 hours.
    VAS måles før administration af hver bupivacainsugetablet samt 60 minutter efter administration for sugetabletgruppen. For kontrolgruppen måles VAS hver anden time.
    E.5.2Secondary end point(s)
    - Reduction of the patient’s opioid use in the lozenge group compared to the opioid use in the control group measured in mg/day
    - Reduction in days on opiods in the trial period for the lozenge group compared to the control group.
    - Nedsættelse af patienternes forbrug af opioid målt i mg/dag for bupivacainsugetablet gruppen sammenlignet med opioid forbruget i kontrolgruppen
    - Nedsættelse af antal dage med opioider i forsøgsperioden for bupivacainsugetablet gruppen sammenlignet med kontrolgruppen
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of trial
    Ved forsøgets afslutning
    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 No
    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 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 Yes
    E.8.2.3.1Comparator description
    Standard smertebehandlingsregime
    Standard pain treatment regime
    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 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
    Sidste besøg for sidste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    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.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)
    Standard pain treatment regime
    Standard smertebehandlingsregime
    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 Decision2014-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-04
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