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    Summary
    EudraCT Number:2015-004495-30
    Sponsor's Protocol Code Number:CYCLOIC-1
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-10-20
    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 ConcernedFinland - Fimea
    A.2EudraCT number2015-004495-30
    A.3Full title of the trial
    Safety of intravesical bladder instillations among patients with severe interstitial cystitis
    Siklosporiini-rakkohuuhteluiden turvallisuus hankalasta interstitiaalisesta virtsarakkotulehduksesta kärsivillä potilailla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of intravesical bladder instillations among patients with severe interstitial cystitis
    Siklosporiini-rakkohuuhteluiden turvallisuus hankalasta interstitiaalisesta virtsarakkotulehduksesta kärsivillä potilailla
    A.4.1Sponsor's protocol code numberCYCLOIC-1
    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 SponsorOulu University Hospital
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOulu University Hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOulu University Hospital
    B.5.2Functional name of contact pointUrologian avohoitoyksikkö
    B.5.3 Address:
    B.5.3.1Street AddressKajaanintie 50
    B.5.3.2Town/ cityOulu
    B.5.3.3Post code90220
    B.5.3.4CountryFinland
    B.5.6E-mailmarkku.h.vaarala@ppshp.fi
    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 SANDIMMUN
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    Intravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.9.4EV Substance CodeSUB06250MIG
    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
    Interstitial cystitis and bladder pain syndrome
    Interstitiaalinen kystiitti ja rakkokipuoireyhtymä
    E.1.1.1Medical condition in easily understood language
    Interstitial cystitis and bladder pain syndrome
    Interstitiaalinen rakkotulehdus ja rakkokipuoireyhtymä
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10071166
    E.1.2Term Bladder pain syndrome
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10011796
    E.1.2Term Cystitis interstitial
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety of intravesical cyclosporine among patients with severe interstitial cystitis/painful bladder syndrome.
    Tutkimuksen tarkoituksena on selvittää, onko virtsarakon sisäisesti annosteltu siklosporiini turvallinen hoitomuoto hankalasta interstitiaalisesta kystiitistä tai rakkokipuoireyhtymästä kärsivillä potilailla.
    E.2.2Secondary objectives of the trial
    The effect of dose to symptoms.
    Annoksen vaikutus oireisiin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age min 20 years
    IC/PBS according to SUFU-criteria minium duration of 6 months
    No suspicion of bladder cancer based on urine cytology and cystoscopy (performed within one year)
    AUA treatment algorhitm level 3 treatments given without sufficient response
    Signed informed consent
    Fertile women commitment to reliable pregnancy preventive method during the trial. Male commitment to abstinence of use of condom during intercourse for 2 days after bladder instillation
    Suitable for cystectomy to treat IC/PBS
    1. Ikä vähintään 20 vuotta
    2. SUFU-määritelmän mukainen IC/BPS vähintään 6 kuukauden ajan
    3. Virtsan sytologian ja kystoskopian (tehtynä vuoden sisällä tutkimuksen aloittamisesta) perusteella ei epäilyä maligniteetista virtsateiden alueella
    4. AUA hoitoalgometrin (liite 1) mukainen vähintään 3. linjan hoito kokeiltu ilman riittävää hoitovastetta
    5. Allekirjoitettu suostumusasiakirja
    6. Naispotilaan sitoutuminen luotettavan ehkäisymenelmän käyttöön tutkimuksen ajan, mikäli fertiili-ikäinen. Miespotilaan sitoutuminen yhdynnästä pidättäytymiseen tai kondomiehkäisyn käyttöön 2 vrk ajan rakkohuuhtelun jälkeen.
    7. Potilas on yleiskuntonsa ja henkisen tilansa puolesta soveltuva osittaiseen virtsarakon poistoleikkaukseen tai koko virtsarakon poistoleikkaukseen hankalaoireisin IC/PBS vuoksi.
    E.4Principal exclusion criteria
    Acute bacterial cystitis
    Severe hypertension (over 160/100 mmHg)
    Malignant disease within 5 years, excluding basal cell carcinoma
    Radiation to pelvis
    Residual urine over 150 ml
    Significant renal detoriation
    Allergy to cyclosporine
    Pregnancy
    Subject not suitable for trial based on investigator evaluation
    1. Akuutti virtsatietulehdus seulontatutkimuksissa (tulehdus voidaan hoitaa ja mikäli kontrollinäyte 2 viikon sisällä osoittaa tulehduksen parantuneen, potilas ei täytä tätä poissulkukriteeriä)
    2. Hankala verenpainetauti (RR yli 160/100 luotettavissa kotimittauksissa ja tutkimuskeskuksessa mitattuna)
    3. Hoidettu syöpä 5 vuoden sisällä, poislukien basaliooma
    4. Lantion alueen sädehoito
    5. Jäännösvirtsamäärä yli 150 ml
    6. Merkittävä munuaisten vajaatoiminta, eGFR <40 ml/min/1.73 m2
    7. Tiedossa oleva yliherkkyys siklosporiinille
    8. Raskaus
    9. Tutkijan arvio potilaan soveltumattomuudesta tutkimukseen tai puutteellisesta sitoutumisesta tutkimuksen läpikäymiseen
    E.5 End points
    E.5.1Primary end point(s)
    Greatest safe intravesical cyclosporine dose.
    Definition of safe dose: measured cyclosporine concentration in blood <50.
    Suurin turvallinen siklosporiiniannos rakkohuuhteluina.
    Annosta pidetään turvallisena kun mitattu siklosporiinipitoisuus (B-CyA) on <50.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before every dose and after 4 hours of every dose, and End of trial visit at 30 (28-32) days.
    Ennen jokaista huuhtelua ja 4 tuntia jokaisen huuhtelun jälkeen. Sekä tutkimuksen päätöskäynnillä päivänä 30 (28-32) tutkimuksen aloittamisesta.
    E.5.2Secondary end point(s)
    The effect of dose to symptoms.
    Based on PORIS-questionnaire score.
    Annoksen vaikutus oireisiin.
    Arvioidaan PORIS-kyselyn pistesummalla.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every visit from visit day 3 to End of trial visit at day 30 (28-32).
    Jokaisella käynnillä käynnistä Päivä 3 tutkimuksen lopetuskäynnille (Päivä 30 (28-32)).
    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 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 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
    Severe adverse events during the trial
    Vakavat haittatapahtumat tutkimushoidon seurauksena
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state6
    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 Decision2015-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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