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    Summary
    EudraCT Number:2013-003239-31
    Sponsor's Protocol Code Number:HOVIR_700
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2013-12-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-003239-31
    A.3Full title of the trial
    A randomised, placebo-controlled, single-centre, double-blind study to evaluate the efficacy, safety and tolerability of topically applied piroxicam gel in patients with recurrent herpes labialis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, placebo-controlled, single-centre, double-blind study to evaluate the efficacy, safety and tolerability of topically applied piroxicam gel in patients with recurrent herpes labialis
    A.3.2Name or abbreviated title of the trial where available
    HOVIR
    A.4.1Sponsor's protocol code numberHOVIR_700
    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 SponsorHOV GmbH
    B.1.3.4CountryGermany
    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 supportHOV GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMediconomics GmbH
    B.5.2Functional name of contact pointClinical Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressMisburger Str. 81b
    B.5.3.2Town/ cityHanover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number00495115609980
    B.5.5Fax number004951156099820
    B.5.6E-mailinfo@mediconomics.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 Yes
    D.2.1.1.1Trade name Pirocutan Gel
    D.2.1.1.2Name of the Marketing Authorisation holderMibe GmbH Arzneimittel
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameHOV11 gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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 placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent Herpes labialis
    E.1.1.1Medical condition in easily understood language
    Recurrent Herpes labialis
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    The primary objective of this clinical study is to evaluate the efficacy of topically applied HOV11 gel versus placebo in the treatment of recurrent herpes labialis by assessment of the severity and duration of typical herpes labialis symptoms.
    E.2.2Secondary objectives of the trial
    course of herpes labialis recurrency during and after the treatment Phase (course of herpes labialis single and cumulated prodromal symptoms over time; course of stronger symptoms over time: erythema, papule, vesicle, ulceration; course of herpes labialis stages over time; time to the occurrence and/ or end of specific symptoms of a herpes labialis recurrency); observation of the expansion of the herpes labialis affected area during and after the treatment Phase (course of the visible signs of the herpes labialis recurrency: length, width and severity of
    lesion); observation of additional symptoms (pain and swelling) over time by means of numerical rating scales; observation of the patient’s and investigator’s efficacy assessments during and after the treatment Phase (severity of the recurrency; improvement of the symptoms)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. females and males, at least 18 years of age,
    2. written signed informed consent form,
    3. at least 3 herpes labialis recurrencies during the past 12 months, but otherwise in good general health,
    4. a history of prodromal symptoms during more than 50% of prior herpes labialis episodes (tingling, tenderness, pain, burning, itching, sensation of tension),
    5. a history of more than 50% of the herpes labialis episodes producing classical lesions (i. e. vesicles, ulcers, and/or a hard crust)
    6. recurrent herpes labialis in the prodromal or erythema stage reported at Visit 1 (day 0).
    E.4Principal exclusion criteria
    1. patients with alcohol or drug-abuse
    2. pregnant or lactating women
    3. women who plan to get pregnant during the time of the study
    4. women of childbearing age who do not use a highly effective method of contraception (contraceptive measures with a Pearl index < 1 are considered highly effective)
    5. known hypersensitivity to piroxicam, to any excipient of the study medication or to other analgesics or antirheumatics (non-steroidal anti-inflammatory drugs)
    6. current participation in another study with an investigational drug or within 30 days Prior to the Screening Visit;
    7. patients who receive any anti-viral medication;
    8. patients with renal function impairments chronic obstructive pulmonary disease
    9. patients with medical or psychiatric conditions which may pose a risk to the patient in this study or adversely interact with relevant study measures or the patient’s ability to participate in the study according to the investigator´s judgment
    10. evidence of an uncooperative attitude or known or suspected inability to comply with the clinical study protocol
    11. patients who are institutionalised due to a regulatory action or court order
    12. if more than 12 hours have passed since the onset of the prodromal herpes labialis symptoms before Visit 1 (day 0)
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    • Maximum score describing the symptoms of an aggravating recurrency (as observed by the investigator in the CRF)
    The symptoms are (local language in brackets):
    1 = prodromal symptoms (prodromale Symptome)
    2 = erythema (Erythema)
    3 = papule (Papeln)
    4 = mild vesicle (leichte Vesikel)
    5 = moderate vesicle (moderate Vesikel)
    6 = severe vesicle (starke Vesikel)
    7 = mild ulceration (leichte Ulzeration)
    8 = moderate ulceration (moderate Ulzeration)
    9 = severe ulceration (starke Ulzeration)
    • Time to maximum score describing the symptoms of an aggravating recurrency (measured from start of treatment)
    • Time to completely healed status measured from start of treatment (first application of study medication) to confirmed healing (by investigator’s diagnosis)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0, 1, 3, 6, 10, 14 by investigator; daily records by patients in the diary
    E.5.2Secondary end point(s)
    Efficacy:
    • Course of herpes labialis single and cumulated prodromal symptoms over time:
    - tingling
    - itching
    - burning
    - tenderness
    - sensation of tension
    • Course of stronger symptoms over time :
    - erythema
    - papules
    - vesicles
    - ulceration
    • Course of herpes labialis stages over time. The 8 stages and single
    symptoms are:
    stage 1 = prodromal phase (tingling, itching, burning, tenderness, sensation of tension)
    stage 2 = erythema phase
    stage 3 = papule phase
    stage 4 = vesicle phase
    stage 5 = ulceration phase
    stage 6 = crusting phase
    stage 7 = healing phase
    stage 8 = healed
    • Time to occurrence and/ or end of specific symptoms of the herpes labialis recurrency
    • Course of the visible signs of the herpes labialis recurrency: length, width and severity of lesion
    • Observation of additional symptoms (pain and swelling) over time by means of numerical rating scales (possible values of 0 to 10)
    • Patient’s and investigator’s assessment of the severity of the recurrency
    • Patient’s and investigator’s assessment of the improvement of symptoms
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, 1, 3, 6, 10, 14
    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 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
    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 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: 106
    F.1.3Elderly (>=65 years) No
    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 state106
    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)
    It is not different from the expected normal treatment of that condition.
    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 Decision2014-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-14
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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