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    Summary
    EudraCT Number:2011-005622-21
    Sponsor's Protocol Code Number:OC002G
    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:2011-12-08
    Trial results View 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 number2011-005622-21
    A.3Full title of the trial
    Clinical Trials with bupivacain lozenge as local anaesthesia under upper gastrointestinal endoscopy
    Klinisk forsøg med bupivacainsugetabletter som lokalbedøvelse af svælget ved gastroskopiundersøgelser
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trials with bupivacaine lozenge as local anaesthesia under upper gastrointestinal endoscopy
    Klinisk forsøg med bupivacainsugetabletter til lokalbedøvelse af svælget ved kikkertundersøgelser
    A.3.2Name or abbreviated title of the trial where available
    UGE lozenge
    A.4.1Sponsor's protocol code numberOC002G
    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.4.1Name of organisation providing supportClinical Research Centre, Hvidovre Hospital
    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 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 number0045 38 62 60 77
    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.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 18010-40-7
    D.3.9.2Current sponsor codeBUPI25
    D.3.9.3Other descriptive nameBupizenge25
    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 Yes
    D.3.11.13.1Other medicinal product typeLocal anaesthetics for oromucosal/oropharyngeal use.
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Xylocain
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameXylocain
    D.3.2Product code 985
    D.3.4Pharmaceutical form Oromucosal spray
    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 INNLidocaine
    D.3.9.1CAS number 137-58-6
    D.3.9.2Current sponsor codeLid10
    D.3.9.3Other descriptive nameLidocaine as a spray
    D.3.9.4EV Substance CodeSUB30131
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    D.3.11.13.1Other medicinal product typeLocal anaesthetics for oromucosal/oropharyngeal use
    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
    Discomfort during upper gastrointestinal endoscopy
    Ubehag ved gastroskopiundersøgelse
    E.1.1.1Medical condition in easily understood language
    Discomfort during gastrointestinal endoscopy
    Ubehag ved kikkertundersøgelse
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    Reduction of discomfort for the patient during upper gastrointestinal endoscopy with administration of bupivacain lozenge compared to lidocaine spray.
    Mindsket ubehag for patienten, herunder svælgreflekser, under en gastroskopiundersøgelse ved administration af bupivacainsugetablet sammenlignet med lidocainspray.
    E.2.2Secondary objectives of the trial
    Improved patientrating of taste and texture when administrating the bupivacain lozenge.
    Forbedret patientvurdering af smag og konsistens ved administration af bupivacainsugetablet.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients undergoing upper gastrointestinal endoscopy.
    - Age between 18 and 80 years.
    - Ability to speak, read and understand danish.
    - Ability to give oral and written consent.
    - Henvisning fra egen læge til gastroskopiundersøgelse i en privat praksis.
    - Alder mellem 18 og 80 år.
    - Skal være i stand til at tale, læse og forstå dansk.
    - Skal være informeret mundtligt og have afgivet skriftligt samtykke, samt underskrevet fuldmagtserklæring.
    E.4Principal exclusion criteria
    - Known allergy to bupivacain.
    - Pregnancy - if in doubt a pregnancy test will be made.
    - Breatfeeding.
    - Use of other medications in addition to the stydy medication in the endoscopy.
    - Kendt allergi overfor bupivacain eller andre lokalanalgetika af amidtypen.
    - Graviditet – patienten bliver spurgt om der anvendes sufficient prævention. Ved tvivl udføres en graviditetstest.
    - Ammende.
    - Anvendelse af anden medicin ud over forsøgsmedicinen i forbindelse med gastroskopiundersøgelsen.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of discomfort for the patient during upper gastrointestinal endoscopy with administration of bupivacain lozenge compared to lidocaine spray.

    The patient rates the gag reflexes and discomfort by:

    - Visual Analog Scale (VAS) 0-10, where 0=no discomfort and 10=extreme discomfort.

    - 4-point scale (no discomfort, easy discomfort, moderate discomfort and difficult discomfort)
    Mindsket ubehag for patienten under en gastroskopiundersøgelse ved administration af bupivacainsugetablet i stedet for lidocainspray.

    Patienten vurderer svælgreflekser og ubehag ved:

    - Visuel Analog Skala (VAS) 0-10, hvor 0 = intet ubehag og 10 = ekstremt ubehag.

    - 4 punktsskala (intet ubehag, let ubehag, moderat ubehag og svær ubehag)
    E.5.1.1Timepoint(s) of evaluation of this end point
    It is evaluated right after the performing of the upper gastrointestinal endoscopy.
    Det evalueres lige efter udførelsen af gastropiundersøgelsen.
    E.5.2Secondary end point(s)
    Improved patientratings of the taste and texture by administration of bupivacain lozenge.
    Forbedret patientvurdering af smag og konsistens ved administrering af bupivacainsugetablet.
    E.5.2.1Timepoint(s) of evaluation of this end point
    It is evaluated right after the performing of the upper gastrointestinal endoscopy.
    Det evalueres lige efter udførelsen af gastropiundersøgelsen.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Optimization of the anaesthetic method when performing upper gastrointestinal endoscopy.
    Optimering af bedøvelsesmetode ved udførelse af gastroskopiundersøgelser.
    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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    The trials will end february 2013.
    Forsøget slutter februar 2013.
    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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-12-08. Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    According to F.3.3.1, if in doubt a pregnancy test will be done.
    Jævnførende F.3.3.1, ved tvivl vil en graviditetstest udføres.
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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 Decision2011-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
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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
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