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    Summary
    EudraCT Number:2006-005788-24
    Sponsor's Protocol Code Number:BA2005/21/02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-10
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-005788-24
    A.3Full title of the trial
    A Randomised, Double-Blind, Single dose, One-Day Early Administration, Multicentre Study comparing the Efficacy and Safety of Acyclovir Lauriad 50 mg muco-adhesive buccal tablet to matching Placebo, in the Treatment of Herpes Labialis in Immunocompetent Patients
    A.3.2Name or abbreviated title of the trial where available
    LIP
    A.4.1Sponsor's protocol code numberBA2005/21/02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBioalliance Pharma
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAcyclovir Lauriad
    D.3.2Product code BA021
    D.3.4Pharmaceutical form Muco-adhesive buccal tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPGingival use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcyclovir
    D.3.9.1CAS number 59277-89-3
    D.3.9.2Current sponsor codeBA021
    D.3.9.3Other descriptive nameAcyclovir Lauriad
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboMuco-adhesive buccal tablet
    D.8.4Route of administration of the placeboGingival use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Herpes labialis
    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
    To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of labial herpes
    E.2.2Secondary objectives of the trial
    To compare the efficacy of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus placebo on:
     The evolution of prodromal symptoms to aborted lesions;
     The healing of non primary lesions;
     The duration of episode;
     The duration of symptoms;
     The healing of aborted lesions;
     The healing of intra-oral and mucosal lesions;
     The incidence of and time to recurrence during 9 months following treatment (ancillary study in selected centres)
    To compare the local tolerability and general safety of acyclovir Lauriad® 50mg muco-adhesive buccal tablet to those of placebo
    To evaluate the concentration of acyclovir in saliva (ancillary study in selected centres) and to assess its relationship with viral load in saliva and efficacy criteria;
    To evaluate the adhesion time of acyclovir Lauriad® (50 mg) muco-adhesive buccal tablet, the incidence of detachment and / or swallow and the number of tablets replaced.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female
    Age > 18 years
    History of recurrent herpes labialis lesions where:
    Recurrence is defined as at least 4 episodes in the preceding 12 months
    Herpes labialis lesions are characterised by their localisation on the cutaneous and/or mucosal surfaces of the lips.
    At least 50% of previous episodes produced classical lesions to the vesicular stage (i.e. episodes that progressed through macula, papule, vesicle, crust and healed);
    Prodromal symptoms (itching, tingling, pain etc.) should precede herpes labialis lesions in at least 50% of the recurrent episodes
    Good general health (ECOG < 2), immunocompetent
    Signed and dated written informed consent
    Women of childbearing potential must have effective contraception method
    Subject must agree to abstain from any mechanical disruption of the prodromal area or lesion (i.e. scrubbing, lancing, shaving the area, rubbing with alcohol...)
    E.4Principal exclusion criteria
    More than 50% of recurrences that aborted spontaneously in the past 12 months
    Primary herpes lesion outside the lips (e.g. nose, chin, etc.)
    Abnormal peri-oral skin condition that might affect the normal course of cold sores (e.g. eczema, psoriasis…)
    Oral diseases whose prodromal symptoms may mimick those of herpes labialis, including recurrent oral aphteous disease
    Oral diseases that might interfere with the evaluation of the efficacy or safety of the treatments, including gingivitis, parondotis, mucositis, oropharyngeal candidiasis…
    History of infection known to be resistant to acyclovir family agents
    Previous vaccination against herpes
    Concomitant treatment likely to interfere with acyclovir
    Treatment with topical steriods in the oral area within 4 weeks prior to study drug administration
    Allergy to any acyclovir containing agents
    Immunocompromised condition, including HIV+
    Unability to properly understand protocol requirements, to follow the study procedures, to complete the patient diary or to start the self-initiation of the treatment
    Upper full or partial dentures with acrylic border in the canine fossa
    Milk allergy or known history of hypersensitivity to one of the components of the products
    Rare hereditary problems of galactose intolerance.
    Lactase enzyme deficiency or glucose galactose malabsorption
    Clinically significant abnormal level of serum creatinine
    Patients whose occupations make them unlikely to return to the clinic within 24h of treatment initiation
    Pregnancy or breast-feeding
    Investigational drug or immunomodulator treatment in the 30 days prior randomisation
    Prior enrollment in this study, except for patients who have already experienced an outbreak during study participation but have not applied the treatment because they couldn’t attend visit 3
    Participation in another therapeutic trial evaluating new drugs or which could interfere with the evolution of herpes labialis or the evaluation of the drug in the study within preceding 30 days
    Share household with another subject already enrolled in the current study
    Patients who do not develop herpes episodes within 6 months after their randomisation in the study will be excluded. They will be required to return the medication to the investigating site
    History of alcoholism or drug abuse
    E.5 End points
    E.5.1Primary end point(s)
    Time To Healing (TTH) of primary vesicular lesion.
    Healing is defined as the loss of crust. Erythema may be present. It will have to be assessed by the investigator.
    The time to healing is the time from the treatment initiation (date and hour recorded) to the healing as defined above.
    The primary vesicular lesion is the first developed lesion. It should be located on the lip and should not extend on more than 1cm outside the lip. Pure intra-oral lesions are not considered as primary lesion.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 days24
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days24
    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.1.3Elderly (>=65 years) Yes
    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 state482
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1369
    F.4.2.2In the whole clinical trial 1950
    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 Decision2007-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-17
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