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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37564   clinical trials with a EudraCT protocol, of which   6160   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).
     
    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:2019-002575-34
    Sponsor's Protocol Code Number:19733
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-16
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-002575-34
    A.3Full title of the trial
    A randomised, placebo-controlled, double-blind, parallel-group, multi-centre, proof-of-concept study to assess the efficacy and safety of BAY 1817080 in patients with overactive bladder (OAB) over a 12-week treatment period.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to evaluate the treatment effect and safety of BAY1817080 in patients with overactive bladder (OAB)
    A.3.2Name or abbreviated title of the trial where available
    19733 OVADER BAY1817080
    A.4.1Sponsor's protocol code number19733
    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 SponsorBayer AG
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trial Contacts
    B.5.3 Address:
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number4930300139003
    B.5.6E-mailclinical-trials-contact@bayer.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 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 nameBAY 1817080 25 mg tablets
    D.3.4Pharmaceutical form 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 INNn/A
    D.3.9.1CAS number n/A
    D.3.9.2Current sponsor codeBAY 1817080
    D.3.9.3Other descriptive nameBAY 1817080
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 nameBAY 1817080 100 mg tablets
    D.3.4Pharmaceutical form 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 INNn/A
    D.3.9.1CAS number n/A
    D.3.9.2Current sponsor codeBAY 1817080
    D.3.9.3Other descriptive nameBAY 1817080
    D.3.9.4EV Substance CodeAS2
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Overactive Bladder
    E.1.1.1Medical condition in easily understood language
    A condition that causes sudden, uncontrolled need or urge to urinate and in some cases may lead to urinary leakage
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.2System Organ Class 100000004857
    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 the efficacy of BAY1817080 125 mg twice a day (BID) in comparison to placebo in the treatment of OAB with urgency urinary incontinence (UUI) over a 12-week treatment period.
    E.2.2Secondary objectives of the trial
    To further evaluate the efficacy of BAY1817080 125 mg BID in comparison to placebo in the treatment of OAB with urgency urinary incontinence (UUI) over a 12-week treatment period.

    To evaluate the safety and tolerability of BAY1817080, the study drug, at a dose of 125 mg taken twice daily in comparison to placebo over a treatment period of up to 12 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria at screening:

    1. Adults ≥ 18 years of age at the time of signing the informed consent
    2. Have “wet” OAB symptoms (urgency, frequency and urinary incontinence) for ≥ 3
    months prior to screening visit
    3. Women of childbearing potential (WOCBP) must agree to use acceptable effective
    or highly effective contraceptive methods (See Section 10.4 for detailed
    contraceptive guidance)
    4. Capable of giving signed informed consent as described in Section 10.1.3 which
    includes compliance with the requirements and restrictions listed in the informed
    consent form (ICF) and in this protocol
    5. Willing and able to complete the electronic bladder diary and questionnaires
    5.1.2

    Inclusion criteria at baseline (to be checked at V3, prior to randomization:

    6. Completion of all 3 days of 3-day electronic bladder diary during run-in phase
    7. Compliance of ≥80% with intake of study intervention during run-in
    8. Frequency of micturition on average ≥ 8 episodes/24 h during the run-in phase
    according to 3-day electronic bladder diary
    9. Frequency of urgency urinary incontinence on average ≥ 1 episode/24 h during the
    run-in phase according to 3-day electronic bladder diary
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    1. Polyuria known or based on the clinical evidence during the run-in phase recorded in the 3-day electronic bladder diary and the investigator´s clinical judgement
    2. Significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator
    3. Post-void residual volume (PVR) > 150 mL at Visit 1 or at Visit 3
    4. In need of catheterization
    5. Clinically significant urinary outflow obstruction, e.g. prostatic hyperplasia, female prolapse of pelvic organs, or any other urinary tract pathology known
    6. Previous pelvic radiation, or previous or current malignant disease of pelvic organs
    7. Neurogenic bladder
    8. Bladder pain syndrome/interstitial cystitis
    9. Recurrent and/or symptomatic bladder stones
    10. Current symptomatic or recent (within 30 days prior to Visit 1), or recurrent (2 or more infections within 6 months, or > 3 infections within 12 months) urinary tract infection
    11. Unexplained macro- or micro-hematuria
    12. Diabetes insipidus
    13. Diabetes mellitus with inadequate glycemic control as indicated by HbA1C result of > 8% at screening
    14. Clinically significant cardiovascular or cerebrovascular disease
    15. Uncontrolled hypertension, despite treatment with antihypertensive(s), indicated by a sitting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg
    16. Clinically significant abnormal electrocardiogram (ECG) at screening
    17. Moderate-to-severe hepatic impairment defined as Child-Pugh Class B or C
    18. Laboratory values outside the inclusion range (as specified in the laboratory manual and in the reports from the central laboratory) before start of study intervention, and considered clinically relevant
    19. At screening:
    o ALT above 2xULN OR
    o AST above 2xULN OR
    o total bilirubin greater than ULN OR
    o AP above 2x ULN OR
    o INR greater than ULN (unless on vitamin K antagonist treatment)
    20. Severe renal impairment as defined by estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 calculated by Modification of Diet in Renal Disease (MDRD) formula
    21. Any other diseases or conditions that according to the investigator can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g., Chronic bowel disease, Crohn’s disease and ulcerative colitis)
    22. Any severe or unstable diseases or medical conditions including psychiatric disorders that might interfere with the conduct of the study, or could jeopardize the safety of the participant, or the interpretation of the results
    23. History of major depression within 2 years prior to screening, or a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder)
    24. Concurrent malignancy or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to screening
    25. Intake of prohibited medication due to potential drug-drug interaction (detailed list of compounds and timeframe are described in Section 6.5)
    26. Use of other treatments that might interfere with the conduct of the study or the Interpretation of the results (details are provided in Section 6.5) e.g.
    a) use of any drug treatment after start of study intervention intended for the OAB/UI symptoms other than the study intervention
    b) neuromodulation therapy and intravesical treatment – less than 12 months prior to screening or at any time during the study
    c) Use of any treatment intended for other conditions but which can affect urinary bladder function during the study (details are provided in Section 6.5)
    d) Non-drug treatment (e.g. physical treatment or acupuncture) – permitted only if initiated ≥4 weeks prior to Screening and planned to be continued during the study
    27. Hypersensitivity to any ingredient of the study intervention
    28. Wish for pregnancy during the study, current pregnancy or lactation, or less than 3 months since delivery prior to visit 1
    29. Major surgery scheduled during the study period
    30. Inability to cooperate with the study procedures for any reason, including limited language comprehension, inability to get to the study site
    31. Abuse of alcohol or medicines, or use of recreational/illicit drugs, as evaluated by the investigator
    32. Previously treated with the study intervention
    33. Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial 3 months prior to screening visit (Visit 1) that might have an impact on the study objectives, at the discretion of the investigator
    34. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person
    35. Otherwise vulnerable participants. Participants who are in custody by order of
    E.5 End points
    E.5.1Primary end point(s)
    Average change from baseline over Week 4, 8 and 12 (end of treatment [EoT]) in mean number of urgency urinary incontinence (UUI) episodes/24 hours based on electronic bladder diary.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline up to 12 weeks
    E.5.2Secondary end point(s)
    1. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of Urgency urinary incontinence (UUI) episodes/24 hours;

    2. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of Urinary incontinence (UI) episodes/24 hours;

    3. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of micturition episodes/24 hours;

    4. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urgency episodes (Grade 3 or 4)/24 hours;

    5. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of nocturia episodes/24 hours;

    6. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean volume voided per micturition;

    7. The incidence of adverse events, drug-related adverse events and taste related adverse events;

    8. The maximum intensity of adverse events per participant.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-6: From baseline up to 12 weeks;

    7-8: From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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:

    The end of the study is defined as the date of the last visit of the last participant in the study.
    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 months11
    E.8.9.1In the Member State concerned days18
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    After the completion of the study the study medication will no longer be available for the participant.

    The study doctor will discuss available standard of care treatment options that best suit the participant following their discontinuation from the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA