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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-001759-22
    Sponsor's Protocol Code Number:PGX401-11
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-001759-22
    A.3Full title of the trial
    Assessment of the efficacy of POLYGYNAX® in the empirical treatment of infectious vaginitis
    International, multicentre, randomised, double-blind, parallel group study, comparative versus miconazole
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test the efficacy of POLYGYNAX® in patients
    presenting with vaginal infections. POLYGYNAX® is compared to
    miconazole followed by a placebo. Miconazole is another active treatment for vaginal infections.
    A.3.2Name or abbreviated title of the trial where available
    PRISM
    A.4.1Sponsor's protocol code numberPGX401-11
    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 SponsorLaboratoire Innotech International
    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 supportLaboratoire Innotech International
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratoire Innotech International
    B.5.2Functional name of contact pointMedical Affairs Department
    B.5.3 Address:
    B.5.3.1Street Address22 avenue Aristide Briand
    B.5.3.2Town/ cityARCUEIL
    B.5.3.3Post code94110
    B.5.3.4CountryFrance
    B.5.4Telephone number0033146151883
    B.5.5Fax number0033146151901
    B.5.6E-mailprism@innothera.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 POLYGYNAX®
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire Innotech International
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Vaginal capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    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.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 GYNODAKTARIN®
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Vaginal capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    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 placeboVaginal capsule, soft
    D.8.4Route of administration of the placeboVaginal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients presenting with abnormal vaginal discharge associated with other vaginal symptoms (i.e. vaginal burning and/or vaginal irritation and/or vaginal pain) clinically evoking infectious vaginitis (bacterial vaginitis, non specific vaginitis or mixed vaginitis) after thorough gynecological examination and for whom an empirical local treatment is warranted.
    E.1.1.1Medical condition in easily understood language
    Patients presenting with abnormal vaginal discharge associated with vaginal burning and/or vaginal irritation and/or vaginal pain and diagnosed with vaginal infection needing a local treatment.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10046950
    E.1.2Term Vaginitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10046914
    E.1.2Term Vaginal infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10001107
    E.1.2Term Acute vaginitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10029562
    E.1.2Term Non-specific vaginitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10062167
    E.1.2Term Vaginitis bacterial
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 study is to demonstrate the superior clinical efficacy of POLYGYNAX® at the End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any) compared to miconazole in the empirical treatment of infectious vaginitis
    E.2.2Secondary objectives of the trial
    • Comparison of the changes in symptoms (from Visit 1 / D1 to Visit 2 / D15 or Premature Discontinuation Visit if any) between the 2 treatments
    • Assessment of the clinical efficacy of the 2 treatments at End of Study Visit (Visit 3 / D22 or Premature Discontinuation Visit if any)
    • Assessment of the safety of the 2 treatments
    • Assessment of the compliance with the 2 treatments
    • Assessment of patients’ and investigators’ global satisfaction with the 2 treatments
    • Description of the microbiological status at Baseline Visit (Visit 1 / D1) and assessment of the proportion of fungal, bacterial and mixed vaginitis, bacterial vaginosis and imbalance of vaginal flora
    • Description of the microbiological changes during follow-up (between Baseline Visit (Visit 1 / D1) and End of Study Visit (Visit 3 / D22 or Premature Discontinuation Visit if any) if a clinical treatment failure is assessed by the investigator and if no alternative or specific treatment is begun before these visits
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female outpatients, aged 18 to 64, who have read, understood, signed and dated the informed consent form
    2. Patient with an abnormal vaginal discharge associated with one (or more) functional vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation clinically evoking an infectious vaginitis:
    • bacterial vaginitis
    • non-specific vaginitis (atypical symptoms)
    • mixed vaginitis (i.e. suprainfected fungal vaginitis)
    and able to receive an empirical local treatment
    3. Patient for whom follow-up by the investigator for 22 days is possible and able/accepts to comply with the study constraints
    4. Patient affiliated to a public health insurance coverage
    E.4Principal exclusion criteria
    1. Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion
    2. Vaginal infection justifying systemic therapy
    3. History of atrophic vaginitis or suspected atrophic vaginitis at inclusion
    4. Patient presenting signs of genital herpes or signs of non-infectious vulvar pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen plannus, contact dermatitis, candida intertrigo, vulval intraepithelial neoplasia (VIN))
    5. Patient with current Sexually Transmitted Infection (STI) and/or patients with clinical suspicion of STI (recent history of STI (within 2 months prior to inclusion), infected partner, suggestive symptoms, etc.)
    6. Patient with underlying debilitating medical conditions
    7. Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments)
    8. Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion
    9. Patient with surgery scheduled during the study
    10. Allergy or hypersensitivity to one of the components of POLYGYNAX® or to one of the components of comparator treatment (miconazole+placebo)
    11. Patient menstruating or patient with menometrorraghia due to hormonal imbalance at the time of inclusion
    12. Patient lactating, or who has delivered within four weeks prior to inclusion
    13. For patients of childbearing age, patient with a positive urine pregnancy test on the day of the Baseline Visit (Visit 1 / D1)
    14. Use of spermicide products (associated or not with a diaphragm) within two weeks prior to inclusion
    15. Patient having used an intra vaginal hormonal treatment (including intra vaginal ring) within four weeks prior to inclusion
    16. For patients of childbearing age, patient not using effective contraception method or using an effective method which needs to be changed or stopped during the study (NB : Use of a latex diaphragm, and/or latex condoms and/or a spermicide is not allowed during the study)
    17. Patient participating or having participated in a clinical trial within four weeks prior to inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Clinical treatment efficacy assessed by the investigator after thorough gynaecological examination and patient’s interview at End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any).
    • Success is defined by resolution (return to patient’s usual gynaecological conditions, i.e. before the episode which warranted inclusion in the study) OR substantial improvement of clinical signs of infectious vaginitis (i.e. abnormal vaginal discharge), and/or vaginal symptoms (vaginal burning and/or vaginal pain, and/or vaginal irritation).
    • Failure is defined by persistence or worsening of symptoms and clinical signs or requirement of an alternative or specific treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Visit 2 on D15 ± 1 day
    If menstrual period at Visit 2, the visit is scheduled the day after the end of menses.
    E.5.2Secondary end point(s)
    • Change in vaginal discharge and in each associated vaginal clinical symptoms (vaginal burning and/or vaginal pain and/or vaginal irritation) compared to Baseline Visit (Visit 1 / D1), by means of daily self-assessment on Visual Analogue Scale (VAS) by the patient from D1 to D14
    • Change in vaginal discharge compared to Baseline Visit (Visit 1 / D1), as assessed by the investigator at End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any) by a leucorrhoea score (0 = absent; 1 = mild: insufficient for speculum collection; 2 = moderate: sufficient for speculum collection; 3 = abundant: visible at the introitus even before speculum introduction). If patients have their menstrual period at Visit 2, the clinical assessment is scheduled the day after the end of menses
    • Clinical treatment efficacy (success/failure) assessed by the investigator after thorough gynaecological examination and patient’s interview at End of Study Visit (Visit 3 / D22 or Premature Discontinuation Visit if any)
    • Number and percentage of adverse events during the study and causal role of study treatments
    • Compliance with treatments (number of vaginal capsules administered between Baseline Visit (Visit 1 / D1) and End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any)
    • Investigator’s global satisfaction assessed at End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any)
    • Patients’ global satisfaction assessed on the eve of End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any)
    • Microbiological status of patients at Baseline Visit (Visit 1 / D1) and proportion of fungal, bacterial and mixed vaginitis, bacterial vaginosis and imbalance of vaginal flora
    • Change in microbiological status between Baseline Visit (Visit 1 / D1) and End of Study Visit (Visit 3 / D22) or Premature Discontinuation Visit if a clinical treatment failure is assessed by the investigator and if no alternative or specific treatment was begun before the Visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    • For change in vaginal discharge and in each associated vaginal clinical symptoms (vaginal burning and/or vaginal pain and/or vaginal irritation) by the patient: Daily patient evaluation between Day 1 and Day 14 in the patient's diary
    • For change in vaginal discharge compared to Baseline Visit by the investigator: Day 15 (± 1 day)
    • For assessment of clinical treament efficacy by the investigator : At Visit 3 on D22 +/- 1 day
    • For AE: Day 15 (± 1 day), Day 22 (± 1 day)
    • For compliance: Day 15 (± 1 day)
    • For investigator's global satisfaction: Day 15 (± 1 day)
    • For patient's global satisfaction: Day 14 (in the patient diary)
    • For microbiological status: Day 1
    • For change of microbiological status: Day 22 (± 1 day)
    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) 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 concerned90
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA115
    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
    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 months14
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    E.8.9.2In all countries concerned by the trial days22
    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: 650
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state450
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 650
    F.4.2.2In the whole clinical trial 650
    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
    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 Decision2015-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-25
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