Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001143-32
    Sponsor's Protocol Code Number:Algofrenelle-01
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-28
    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 ConcernedGreece - EOF
    A.2EudraCT number2018-001143-32
    A.3Full title of the trial
    Efficacy of a new ibuprofen formulation for vaginal application
    Αποτελεσματικότητα μίας νέας φαρμακοτεχνικής μορφής ιβουπροφαίνης για κολπική εφαρμογή
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy of ibuprofen vaginal solution
    Μελέτη της αποτελεσματικότητας κολπικού διαλύματος ιβουπροφαίνης
    A.4.1Sponsor's protocol code numberAlgofrenelle-01
    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 SponsorIoulia and Irene Tseti Pharmaceutical Laboratories S.A., d.t. "Intermed S.A."
    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 supportIoulia and Irene Tseti Pharmaceutical Laboratories S.A.
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIoulia and Irene Tseti Pharmaceutical Laboratories S.A.
    B.5.2Functional name of contact pointRegulatory Affairs department
    B.5.3 Address:
    B.5.3.1Street Address27, Kalyftaki street
    B.5.3.2Town/ cityKifissia/Athens
    B.5.3.3Post code14564
    B.5.3.4CountryGreece
    B.5.4Telephone number302106253905
    B.5.5Fax number302106253906
    B.5.6E-mailsoumelas@uni-pharma.gr
    D. IMP Identification
    D.IMP: 1
    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 Algofren® 400 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderIoulia and Irene Tseti Pharmaceutical Laboratories S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBUPROFEN
    D.3.9.1CAS number 15687-27-1
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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 Algofrenelle® Vaginal solution 1% w/v
    D.2.1.1.2Name of the Marketing Authorisation holderIoulia and Irene Tseti Pharmaceutical Laboratories S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 solution
    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 INNIBUPROFEN LYSINATE
    D.3.9.1CAS number 57469-77-9
    D.3.9.3Other descriptive nameIBUPROFEN LYSINE
    D.3.9.4EV Substance CodeSUB02626MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Analgesic and anti-inflammatory action after gynecological surgical procedures
    Αναλγητική και αντιφλεγμονώδης δράση μετά από γυναικολογικές χειρουργικές επεμβάσεις
    E.1.1.1Medical condition in easily understood language
    Post-operative pain management after gynecological surgery
    Διαχείριση μετεγχειρητικού πόνου μετά από γυναικολογικές χειρουργικές επεμβάσεις
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10053467
    E.1.2Term Antiinflammatory therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10036276
    E.1.2Term Postoperative analgesia
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate postoperative effectiveness and safety of ibuprofen lysinate vaginal solution for a 4 days monitoring period (D1-D4)
    Σκοπός της παρούσας μελέτης είναι να διερευνήσει την αποτελεσματικότητα διαλύματος ibuprofen lysinate για κολπική χρήση σε ασθενείς κατά τη διάρκεια μετεγχειρητικής περιόδου παρακολούθησης 4 ημερών (D1-D4)
    E.2.2Secondary objectives of the trial
    Product safety assessment based on adverse events recording
    Εκτίμηση της ασφάλειας του προϊόντος μέσω καταγραφής τυχόν ανεπιθύμητων συμβάντων
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Study population: 150 female patients (18-83 years old) who after signing inform consent form they will undergo one of the following surgical procedures:
    - Anterior colporraphy
    - Posterior colporraphy
    - Vaginal hysterectomy
    - Perineorraphy
    - Abdominal hysterectomy
    - Fibroid removal
    - Laparoscopic procedures
    Vaginal swabs will be obtained pre and post operatively for estimation of inflammation markers.
    Ο πληθυσμός της μελέτης αποτελείται από 150 γυναίκες (18<ηλικία≤83 ετών) οι οποίες έχουν υπογράψει συγκατάθεση και πρόκειται να υποβληθούν σε μια από τις παρακάτω χειρουργικές επεμβάσεις:
    • κολπική υστερεκτομή
    • πρόσθια κολπορραφία
    • οπίσθια κολπορραφία
    • περινεορραφή
    • κοιλιακή υστερεκτομή
    • ινομυωματεκτομή
    • λαπαρασκοπικές επεμβάσεις
    Οι γυναίκες που θα συμπεριληφθούν στη μελέτη θα υποβληθούν σε καλλιέργεια κολπικού υγρού προεγχειρητικά, καθώς και στο τέλος της θεραπείας, με σκοπό τη μέτρηση των δεικτών φλεγμονής.
    E.4Principal exclusion criteria
    Patients younger than 18 and older than 83 years old, history of allergy or intolerance to ibuprofen or NSAIDs, history ulceration and/or gastrointestinal haemorrhage (2 or more different episodes), severe heart failure, not well controlled hypertension (fluid retention and oedema have been reported with NSAIDs treatment), pregnancy and breastfeeding, concomitant administration of COX-2 inhibitors, medication that may increase the risk of ulceration and haemorrhage such as steroids, anticoagulants e.g. warfarin, or antiplatelet agents e.g. aspirin. Patients with active bleeding one the first post-operative day will be excluded from the study.
    Τα κριτήρια αποκλεισμού περιλαμβάνουν άτομα κάτω των 18 ή άνω των 83 ετών, προηγούμενη τεκμηριωμένη δυσανεξία στην ιβουπροφαίνη ή σε μη στεροειδή αντιφλεγμονώδη φάρμακα (ΜΣΑΦ), ιστορικό αιμορραγίας του γαστρεντερικού ή διάτρησης που σχετίζονται με προηγούμενη ενεργό θεραπεία ή ιστορικό υποτροπιάζουσας αιμορραγίας του γαστρεντερικού/πεπτικού έλκους (που ορίζεται ως δύο ή περισσότερα ξεχωριστά επεισόδια αποδεδειγμένου έλκους ή αιμορραγίας), σοβαρή καρδιακή ανεπάρκεια, ασθενείς με μη καλά ρυθμιζόμενη υπέρταση ή/και καρδιακής ανεπάρκειας (σε ταυτόχρονη θεραπεία με ΜΣΑΦ έχει αναφερθεί κατακράτηση υγρών και οίδημα), κύηση ή θηλασμός, συγχορήγηση με από του στόματος ΜΣΑΦ εκλεκτικών αναστολέων της COX- 2, ασθενείς που λαμβάνουν ταυτόχρονα φάρμακα, τα οποία ενδέχεται να αυξήσουν τον κίνδυνο έλκους ή αιμορραγίας, όπως τα από του στόματος κορτικοστεροειδή, αντιπηκτικά όπως η βαρφαρίνη, εκλεκτικοί αναστολείς της επαναπρόσληψης σεροτονίνης ή αντιαιμοπεταλιακοί παράγοντες όπως η ασπιρίνη. Από τη μελέτη θα εξαιρούνται ασθενείς με ενεργό αιμορραγία κατά την πρώτη μετεγχειρητική ημέρα.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy assessment of ibuprofen lysinate vaginal solution regarding a) pain reduction based on visual VAS pain scale and b) improvement of inflammation markers based on vaginal swabs cultivation preoperatively and at the end of treatment period (Day 4)
    Η αξιολόγηση των αποτελεσμάτων θα πραγματοποιηθεί κατά την τελευταία ημέρα (D4) με μέτρηση της ύφεσης της έντασης του πόνου μέσω κλίμακας πόνου VAS, ενώ θα ληφθεί και καλλιέργεια κολπικού υγρού προεγχειρητικά και κατά το τέλος της θεραπείας (ημέρα D4) με σκοπό τη μέτρηση των δεικτών φλεγμονής
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment period (Day 4)
    Κατά την τέταρτη ημέρα (D4)
    E.5.2Secondary end point(s)
    Product safety assessment based on adverse events recording
    Εκτίμηση της ασφάλειας του προϊόντος μέσω καταγραφής τυχόν ανεπιθύμητων συμβάντων
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of treatment period (Day 4)
    Κατά την τέταρτη ημέρα (D4)
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.5The 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 years
    E.8.9.1In the Member State concerned months42
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state150
    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 Decision2018-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 19:34:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA