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    Summary
    EudraCT Number:2015-004013-25
    Sponsor's Protocol Code Number:IMBE-01/2015
    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:2016-07-25
    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 number2015-004013-25
    A.3Full title of the trial
    Mirabegron in the management of lower urinary tract symptoms (LUTS) related to double-J (JJ) ureteral stents.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mirabegron in the management of lower urinary tract symptoms (LUTS) related to double-J (JJ) ureteral stents.
    A.3.2Name or abbreviated title of the trial where available
    BET-JJ
    A.4.1Sponsor's protocol code numberIMBE-01/2015
    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 SponsorInstitute of Molecular Medicine and Biomedical Research- I.M.B.E.
    B.1.3.4CountryGreece
    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 supportAstellas Pharma Europe Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHealth Data Specialists Ltd
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street AddressKatehaki 22
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code11525
    B.5.3.4CountryGreece
    B.5.4Telephone number302106997247
    B.5.5Fax number302106997246
    B.5.6E-mailzoi.alevizatou@heads.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 Yes
    D.2.1.1.1Trade name Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namemirabegron
    D.3.2Product code YM178
    D.3.4Pharmaceutical form Prolonged-release 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 INNmirabegron
    D.3.9.1CAS number 223673-61-8
    D.3.9.2Current sponsor codeYM178
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboProlonged-release 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
    Insertion of a JJ stent, prior to extracorporal shock wave lithotripsy (ESWL) and post ureterolithotripsy.
    E.1.1.1Medical condition in easily understood language
    insertion of a JJ stent, prior to extracorporal shock wave lithotripsy (ESWL) and post ureterolithotripsy.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10046707
    E.1.2Term Urolithiasis
    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
    The study’s primary objective is to evaluate the efficacy of Mirabegron in decreasing JJ- related LUTS for urolithiasis when compared to placebo.
    E.2.2Secondary objectives of the trial
    The study’s secondary objective is to evaluate if there is an improvement in health related quality of life (HRQoL) of treatment with Mirabegron versus placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject is male or female and at least 18 years of age;
    • IEC/IRB -approved written Informed Consent (IC) and privacy language as per national regulations has been obtained from the subject or legally authorized representative prior to any study-related procedures (including discontinuation of prohibited medication, if applicable);
    • Female subject who is of childbearing potential* must have a negative urine pregnancy test at screening and must be using highly effective contraception.
    • Female subject must not be breastfeeding at Screening or during the study period and for 28 days after final IMP administration;
    • Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final IMP administration;
    • Male subjects and their female spouse/partners who are of childbearing potential must be using highly effective contraception starting at Screening and continue throughout the study period and for 90 days after final IMP administration;
    • Male subject must not donate sperm starting at Screening and throughout the study period and for at least 90 days after final IMP administration;
    • Insertion of the same JJ Stent (Percuflex, Boston Scientific, 4.8 Fr, 26 cm)
    • No history of JJ stent insertion
    • Estimated duration of stenting: 2 weeks
    * A female subject is either:
    • Of non-childbearing potential:
    - Post-menopausal (defined as at least 1 year without any menses) prior to registration or
    - Documented surgically sterile (at least 1 month prior to registration or status post
    hysterectomy)
    • Or, if of childbearing potential,
    - Must have a negative urine pregnancy test prior study registration
    - Must use effective form of birth control throughout the study.

    Acceptable forms of birth control include:
    - established use of oral, injected or implanted hormonal methods of contraception
    - placement of an intrauterine device (IUD) or intrauterine system (IUS)
    - barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/suppository)
    E.4Principal exclusion criteria
    • Bilateral ureteral stents to be inserted
    • JJ stent already in situ prior to ureteroscopy
    • Patients with congenital renal abnormalities (ie: horseshoe kidney, ectopic kidney, etc)
    • Patients with urinary diversion
    • Patients with a history of interstitial cystitis/painful bladder syndrome, chronic prostatitis, or neurogenic bladder.
    • Indwelling foley catheter
    • Urinary tract infection (urinalysis)
    • Patients currently taking antimuscarinics, Mirabegron, or α-blockers
    • Patients with contraindications to receive Mirabegron (ie: urinary retention, end-stage renal disease, orthostatic hypotension, uncontrolled hypertension, known QT prolongation, severe aortic regurgitation), significant cognitive impairment, pregnancy, and active urinary tract infection
    • Suspected or confirmed ureteral perforation
    • Placement of a JJ stent after an open procedure
    • Uncontrolled Hypertension (SBP≥180 mmHg and/or DBP≥110mmHg)
    • Patients with severe renal impairment concomitantly receiving strong CYP3A inhibitors
    • Patients with severe hepatic impairment and patients with moderate hepatic impairment concomitantly receiving strong CYP3A inhibitors
    • Patients with Bladder Outlet Obstruction (BOO)
    • Patients with hypersensitivity in Mirabegron or to any of the following excipients: polyethyleneglycols, butylhydroxytoluene, magnesium stearate, hypromellose, Iron oxide yellow (E172)
    • Participation in another interventional study one month before inclusion of the patient in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Difference between the two arms in the average urinary symptoms score of visits 2 and 3 as reported in the Ureteral Stent Symptom Questionnaire (USSQ).
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of subjects' follow up
    E.5.2Secondary end point(s)
    1. Difference between the two arms in the urinary symptoms score of visit 2 as reported in the USSQ.
    2. Difference between the two arms in the urinary symptoms score of visit 3 as reported in the USSQ.
    3. Difference between the two arms in the average score of visits 2 and 3 in the remaining USSQ domains (pain symptom index, general health index, work performance index, sexual matters index).
    4. Difference between the two arms in the score of visit 2 in the remaining USSQ domains (pain symptom index, general health index, work performance index, sexual matters index).
    5. Difference between the two arms in the score of visit 3 in the remaining USSQ domains (pain symptom index, general health index, work performance index, sexual matters index).
    6. Difference between the two arms in the average daily VAS measurements.
    7. Difference between the two arms in the average VAS measurements of the period between visit2 and visit 3.
    8. Difference between the two arms in the number of days for duration of JJ stent in situ.
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of subjects' follow up
    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 No
    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
    HRQoL
    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 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 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 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 years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days15
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    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 state78
    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 Decision2016-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-05-11
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