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    Summary
    EudraCT Number:2011-002386-38
    Sponsor's Protocol Code Number:CLVS100VER
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-08-30
    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 ConcernedGreece - EOF
    A.2EudraCT number2011-002386-38
    A.3Full title of the trial
    Μονοκεντρική, τυχαιοποιημένη, διπλή-τυφλή, συγκριτική με πρωτότυπο φάρμακο κλινική μελέτη για την αξιολόγηση της αποτελεσματικότητας και της ασφάλειας της θεραπείας με Clindamycin vaginal suppositories 100 mg σε ασθενείς με κολπίτιδα.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ΜΕΛΕΤΗ ΣΥΓΚΡΙΤΙΚΗΣ ΑΞΙΟΛΟΓΗΣΗΣ ΤΟΥ CLINDAMYCIN/VERISFIELD VAGINAL SUPPOSITORIES 100mg VS DALACIN /PFIZER VAGINAL SUPPOSITORIES 100mg.
    A.4.1Sponsor's protocol code numberCLVS100VER
    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 SponsorVERISFIELD (UK) LTD
    B.1.3.4CountryGreece
    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 supportVERISFIELD (UK) LTD
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVERISFIELD (UK) LTD
    B.5.2Functional name of contact pointCLINICAL TRIALS DEPARTMENT
    B.5.3 Address:
    B.5.3.1Street AddressVYRONOS 8
    B.5.3.2Town/ cityHALANDRI
    B.5.3.3Post code15231
    B.5.3.4CountryGreece
    B.5.4Telephone number00302107475196
    B.5.5Fax number00302107475197
    B.5.6E-mailinfo@verisfield.gr
    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 nameCLINDAMYCIN/VERISFIELD VAGINAL SUPPOSITORIES 100mg
    D.3.4Pharmaceutical form Vaginal delivery system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLINDAMYCIN PHOSPHATE
    D.3.9.1CAS number 24729-96-2
    D.3.9.4EV Substance CodeSUB01344MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 DALACIN
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 delivery system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLINDAMYCIN PHOSPHATE
    D.3.9.1CAS number 24729-96-2
    D.3.9.4EV Substance CodeSUB01344MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Bacterial Vaginosis
    E.1.1.1Medical condition in easily understood language
    Vaginosis due to bacterial infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10004055
    E.1.2Term Bacterial vaginosis
    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
    Σκοπός της μελέτης είναι ο συγκριτικός έλεγχος της αποτελεσματικότητας της τοπικής θεραπείας με κολπικά υπόθετα Clindamycin vaginal suppositories 100 mg της εταιρείας Verisfield (UK) Ltd και η θεραπευτική σύγκριση του προϊόντος με το πρωτότυπο φάρμακο (Dalacin/Pfizer, vaginal suppositories 100 mg), σε ασθενείς με βακτηριακή κολπίτιδα.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Γυναίκες που πληρούν τα ακόλουθα κριτήρια κατά την επίσκεψη έναρξης της μελέτης, είναι κατάλληλες για να συμμετάσχουν στη μελέτη αυτή:
    1. Ασθενείς με βακτηριακή κολπίτιδα, διαγνωσμένη με βάση τα κριτήρια του Amsel και Nugent.
    2. Γυναίκες ηλικίας 18 και 54 ετών, προ-εμμηνοπαυσιακές.
    3. Ασθενείς που είναι σε θέση να διαβάσουν και να κατανοήσουν το Ενημερωτικό Φυλλάδιο της μελέτης.
    4. Ασθενείς που υπέγραψαν τη Δήλωση Συγκατάθεσης μετά από Ενημέρωση.
    5. Γυναίκες οι οποίες, κατά τη γνώμη του ερευνητή, είναι υγιείς σε καλή φυσική κατάσταση βάσει της εξέτασης, του ιατρικού ιστορικού και των ζωτικών σημείων.
    6. Γυναίκες που είναι πρόθυμες και ικανές να προσέλθουν και δεύτερη φορά για τις ανάγκες της μελέτης εντός των επιτρεπόμενων χρονικών ορίων.
    E.4Principal exclusion criteria
    Γυναίκες που πληρούν ένα ή περισσότερα από τα ακόλουθα κριτήρια στην επίσκεψη έναρξης ή κατά τη διάρκεια της μελέτης δεν μπορούν να συμμετάσχουν στη μελέτη:
    1. Γυναίκες που συμμετέχουν ή έχουν συμμετάσχει παλαιότερα (<1 μήνα) σε άλλη κλινική δοκιμή.
    2. Γυναίκες που χρησιμοποίησαν πρόσφατα (<2 εβδομάδες), ή χρησιμοποιούν ταυτόχρονα φαρμακευτική αγωγή για την αντιμετώπιση της βακτηριακής κολπίτιδας τοπικά ή συστηματικά.
    3. Γυναίκες που χρησιμοποίησαν πρόσφατα (<2 εβδομάδες), ή χρησιμοποιούν ταυτόχρονα οποιοδήποτε αντιβιοτικό.
    4. Γυναίκες με καρδιαγγειακή, νεοπλασματική, αιματολογική, ηπατική, νευρολογική, νεφρική, ενδοκρινική και γαστρεντερική σοβαρή νόσο.
    5. Γυναίκες στην εγκυμοσύνη ή γαλουχία.
    6. Γυναίκες οι οποίες δεν είναι πρόθυμες να απέχουν για τη διάρκεια της θεραπείας από κολπική σεξουαλική επαφή.
    7. Ιστορικό ελκώδους κολίτιδας, ή εντερίτιδας ή φλεγμονώδους νόσου του εντέρου ή κολίτιδας από αντιβιοτικά (ψευδομεμβρανώδης κολίτιδα).
    8. Γνωστή ύπαρξη μυκητιασικής κολπίτιδας, Neisseria gonorrhoeae, Trichomonas vaginalis, Chlamydia trachomatis, Streptococcus agalactiae, Herpes simplex virus-2 ή εργαστηριακή επιβεβαίωση της ύπαρξης των συγκεκριμένων παθήσεων.
    9. Γυναίκες με γνωστή υπερευαισθησία στη κλινδαμυκίνη ή στα έκδοχα του προϊόντος.
    10. Γυναίκες οι οποίες, κατά τη γνώμη του ερευνητή, δεν θα συμμορφωθούν με το πρωτόκολλο της κλινικής μελέτης ή δεν κατανοούν το πρωτόκολλο.
    E.5 End points
    E.5.1Primary end point(s)
    Κύρια παράμετρος της μελέτης είναι η ίαση της ασθενούς οριζόμενη ως η απουσία τριών ή τεσσάρων κριτηρίων του Amsel (ύπαρξη ενός ή κανενός). Τα ποσοστά των ασθενών που ιάθηκαν θα συγκριθούν μεταξύ των δύο θεραπευτικών ομάδων.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7-12 ημέρες
    E.5.2Secondary end point(s)
    (α) Κλίμακα IGII (Investigator Global Improvement Index): Κλινική εκτίμηση της εξέλιξης των συμπτωμάτων της κολπίτιδας, από τον Ερευνητή και (β) Κλίμακα PGII (Patient Global Improvement Index): Κλινική εκτίμηση της εξέλιξης των συμπτωμάτων της κολπίτιδας, από την ασθενή.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7-12 ημέρες
    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 Yes
    E.6.13.1Other scope of the trial description
    Therapeutic Non-Inferiority
    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 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.8.5The 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
    Last visit of the last subject.
    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
    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 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: 200
    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 state200
    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 Decision2011-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-19
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