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    Summary
    EudraCT Number:2021-003929-30
    Sponsor's Protocol Code Number:1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-08-18
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-003929-30
    A.3Full title of the trial
    INFLUENCE OF OXYBUTYNIN - MEDRING LIGALLI ON OVERACTIVE BLADDER SYMPTOMS IN WOMEN
    De invloed van oxybutynine-MedRing Ligalli op symptomen van overactieve blaas in vrouwen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INFLUENCE OF OXYBUTYNIN - MEDRING LIGALLI ON OVERACTIVE BLADDER SYMPTOMS IN WOMEN
    De invloed van oxybutynine-MedRing Ligalli op symptomen van overactieve blaas in vrouwen
    A.3.2Name or abbreviated title of the trial where available
    MedRing-04
    MedRing-04
    A.4.1Sponsor's protocol code number1
    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 SponsorLigalli BV
    B.1.3.4CountryNetherlands
    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 supportLiGalli BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLigalli BV
    B.5.2Functional name of contact pointregina Hart
    B.5.3 Address:
    B.5.3.1Street AddressKoninginnegracht 33
    B.5.3.2Town/ cityDen Haag
    B.5.3.3Post code2514 AC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31655794412
    B.5.5Fax number31655794412
    B.5.6E-mailreginahart@tiscali.nl
    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 Oxybutynin Hydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderCorden Pharma Chenove 47, Rue de Longvic France - 21300 Chenove
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Solution for infusion in administration system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    Not mentioned (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 Yes
    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
    urinary urge incontinence
    overactieve blaas
    E.1.1.1Medical condition in easily understood language
    high urge to urinate, over active bladder
    overactieve blaas
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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 assess the influence of intravaginal oxybutynin administration by the MedRing on bladder filling phase in OAB patients
    De MedRing is gemaakt om elektronisch medicijnen in de vagina af te geven. In dit onderzoek zal een geregistreerd medicijn, oxybutynine, via de MedRing in de vagina worden afgegeven.
    Het doel van het onderzoek is om te kijken of op deze manier oxybutynine in het bloed terecht komt.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of the intra-vaginal delivery of oxybutynin via the MedRing in OAB patients
    Ook wordt er gekeken of dit een veilige en verdraagbare methode is om oxybutynine te geven.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing to give written informed consent and willing and able to comply with the study protocol.
    2. Female subjects aged between 18 and 70 years (inclusive)
    3. Women diagnosed with OAB according to the definition of the International Continence Society (ICS), and responding with a score 3 or higher on question 5a of the ICIQ questionnaire “do you have to rush to the toilet to urinate”?
    4. Subject is in good general health, according to the investigator’s judgement based on medical history, vital signs, physical examination, electrocardiogram (ECG), and laboratory tests performed.
    5. Body mass index between 18-32 kg∙m2 (inclusive) and with a minimum body weight of 50 kg at screening.
    6. Ability to communicate well with the investigator in the Dutch language and willing to comply with the study restrictions.
    7. Using adequate contraception (if applicable).
    1. Bereid om schriftelijke geïnformeerde toestemming te geven en bereid en in staat om te voldoen aan het onderzoeksprotocol.
    2. Vrouwelijke proefpersonen tussen 18 en 70 jaar (inclusief)
    3. Vrouwen gediagnosticeerd met OAB volgens de definitie van de International Continence Society (ICS), en een score van 3 of hoger hebben op vraag 5a van de ICIQ-vragenlijst "moet je je naar het toilet haasten om te plassen"?
    4. De proefpersoon verkeert in goede algemene gezondheid, volgens het oordeel van de onderzoeker op basis van medische geschiedenis, vitale functies, lichamelijk onderzoek, elektrocardiogram (ECG) en uitgevoerde laboratoriumtests.
    5. Body mass index tussen 18-32 kg∙m2 (inclusief) en met een minimum lichaamsgewicht van 50 kg bij screening.
    6. Goed kunnen communiceren met de onderzoeker in de Nederlandse taal en bereid zijn om de studiebeperkingen na te leven.
    7. Het gebruik van adequate anticonceptie (indien van toepassing).
    E.4Principal exclusion criteria
    1. Presence of virginity.
    2. History of sexual abuse/violence.
    3. Menstrual bleeding or withdrawal bleeding from oral contraceptive pill expected to occur during conduction of the study.
    4. Positive urinary pregnancy test at screening or at baseline and/or lactating.
    5. Having given birth vaginally or by caesarean section 6 months prior to screening
    6. Having had sexual intercourse or objects inserted vaginally that could potentially lacerate or damage the vaginal wall 24 hours prior to dosing.
    7. Medical history of intra- and/or transvaginal operations that in the opinion of the investigator may interfere with placement or stability of the MedRing or absorption of oxybutynin.
    8. Any known significant allergic reactions (urticaria or anaphylaxis) against oxybutynin, or multiple drug allergies (non-active hay fever is acceptable), or known hypersensitivity to components of the MedRing (polypropylene, styrene triblock copolymer, coloring agents, coating, glue).
    9. Participation in any marketed or investigational drug or device study within 3 months or 5 half-lives (whichever is longer) prior to dosing.
    10. Botox administration in the pelvic area less than 12 months ago.
    11. Use of any prescription medication and any other substance that in the opinion of the investigators may influence the outcome of the study within 21 days prior to dosing.
    12. Use of alcohol during the 24 hours prior to Day 1 of the study.
    13. Any other condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the subject.
    14. Presence of significant postvoid residual urine determined as >100 ml estimated by ultrasound immediately postvoiding.
    1. Aanwezigheid van maagdelijkheid.
    2. Geschiedenis van seksueel misbruik/geweld.
    3. Menstruele bloedingen of onttrekkingsbloedingen van orale anticonceptiepil die naar verwachting zullen optreden tijdens de uitvoering van het onderzoek.
    4. Positieve zwangerschapstest op de urine bij screening of bij baseline en/of borstvoeding.
    5. Vaginaal of via een keizersnede 6 maanden voor de screening zijn bevallen
    6. Geslachtsgemeenschap of voorwerpen vaginaal hebben ingebracht die mogelijk de vaginale wand 24 uur vóór de dosering kunnen scheuren of beschadigen.
    7. Medische voorgeschiedenis van intra- en/of transvaginale operaties die naar het oordeel van de onderzoeker de plaatsing of stabiliteit van de MedRing of absorptie van oxybutynine kunnen verstoren.
    8. Alle bekende significante allergische reacties (urticaria of anafylaxie) tegen oxybutynine, of meerdere medicijnallergieën (niet-actieve hooikoorts is acceptabel), of bekende overgevoeligheid voor componenten van de MedRing (polypropyleen, styreen triblock copolymeer, kleurstoffen, coating, lijm).
    9. Deelname aan een op de markt gebracht of experimenteel geneesmiddel of hulpmiddelonderzoek binnen 3 maanden of 5 halfwaardetijden (afhankelijk van wat langer is) voorafgaand aan de dosering.
    10. Botox toediening in het bekkengebied minder dan 12 maanden geleden.
    11. Gebruik van voorgeschreven medicatie en elke andere stof die naar de mening van de onderzoekers de uitkomst van het onderzoek binnen 21 dagen voorafgaand aan de dosering kan beïnvloeden.
    12. Gebruik van alcohol gedurende de 24 uur voorafgaand aan dag 1 van het onderzoek.
    13. Elke andere voorwaarde die naar het oordeel van de onderzoeker het onderzoek of het welzijn van de proefpersoon zou bemoeilijken of in gevaar zou brengen.
    13. Elke andere voorwaarde die naar de mening van de onderzoeker de studie of het welzijn van de proefpersoon zou compliceren of in gevaar zou brengen.
    14. Aanwezigheid van significante postvoïde resturine bepaald als >100 ml geschat door echografie onmiddellijk na het voïderen.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints, related to PD will be evaluated based on the subject’s response on the sensation meter. The sensation meter has been studied before for this purpose and the endpoints are based on these studies [9,10,11]. This study will assess the plasma level of oxybutynin at the various stages of urge sensations to evaluate the possible direct effect of local (vaginal) administration of oxybutynin, before the maximum plasma level is reached.
    De primaire eindpunten, gerelateerd aan PD, worden geëvalueerd op basis van de respons van de proefpersoon op de sensatiemeter. De sensatiemeter is hiervoor al eerder onderzocht en de eindpunten zijn gebaseerd op deze studies [9,10,11]. Deze studie zal het plasmaniveau van oxybutynine in de verschillende stadia van aandrangsensaties beoordelen om het mogelijke directe effect van lokale (vaginale) toediening van oxybutynine te evalueren, voordat het maximale plasmaniveau wordt bereikt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle 3: Direct effect.
    o Starts drinking protocol
    o activation ring 10 minutes before expected bladder sensation (from Cycle 1 and2).
    o At 50% / 75% and 100% of full bladder sensation – PK blood sample taken.
    o Fill questionnaire anticholinergic side effects
    Cyclus 3: Directe werking.
    o Begint met drinkprotocol
    o activering van de ring 10 minuten vóór het verwachte blaasgevoel (vanaf cyclus 1 en 2).
    o Bij 50% / 75% en 100% van het volle blaasgevoel – PK bloedmonster genomen.
    o Vragenlijst anticholinergische bijwerkingen invullen
    E.5.2Secondary end point(s)
    Secondary endpoints will focus on safety and are:
    • all AEs with a focus on treatment-emergent and serious AEs, as a general safety endpoint.
    • Anticholinergic side effects (dry mouth, headache, abdominal pain) to assess the expected anticholinergic side effects related to the use oxybutynin.
    • Local effects (irritation) to assess the local tolerance of the MedRing in combination with vaginal delivery of oxybutynin.
    • Physical examination (vital signs and in speculum examination as a general safety endpoint.
    • alle bijwerkingen met een focus op behandelingsopkomende en ernstige bijwerkingen, als algemeen veiligheidseindpunt.
    • Anticholinergische bijwerkingen (droge mond, hoofdpijn, buikpijn) om de verwachte anticholinergische bijwerkingen gerelateerd aan het gebruik van oxybutynine te beoordelen.
    • Lokale effecten (irritatie) om de lokale tolerantie van de MedRing in combinatie met vaginale levering van oxybutynine te beoordelen.
    • Lichamelijk onderzoek (vitale functies en bij speculumonderzoek als algemeen veiligheidseindpunt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    CYcle 3 and 4
    Cycle 3 and 4
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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
    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 months0
    E.8.9.1In the Member State concerned 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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state9
    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)
    telephone call 5-10 days after last dose
    telefoongesprek 5-10 dagen na de laaste dosis
    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 Decision2022-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-24
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