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Astellas Study ID
178-CL-008

Study to test the efficacy and safety of YM178 in subjects with symptoms of overactive bladder

Astellas Study ID
NCT01604928
Clinicaltrials.gov ID
NCT01604928
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and tolterodine to treat patients with symptoms of over active bladder.

Additional Study Details

Phase
2
Product
  • YM178
  • tolterodine
  • Placebo
    • Type
    Interventional
    Masking
    Double (Participant, Investigator)
    Enrollment number
    260
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Download Document(s)
    Plain Language Summary
    Available Language(s): English
    Download Document(s)

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    Would you like more information about clinical trial sites that are recruiting participants for Study to test the efficacy and safety of YM178 in subjects with symptoms of overactive bladder? Contact us by filling out your information to the right and we’ll respond to you.

    • A caregiver
    • A healthcare provider
    • A parent
    • A patient
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

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      Completed
      Site: 20
      Prague, Czech Republic, 180 81
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      Completed
      Site: 21
      Usti nad Labem, Czech Republic, 40001
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      Completed
      Site: 43
      Miranda de Ebro, Spain, 09200
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      Completed
      Site: 11
      Gent, Belgium, 9000
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      Completed
      Site: 25
      Melnik, Czech Republic, 276 01
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      Completed
      Site: 64
      Bimingham, United Kingdom, B15 2TG
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      Completed
      Site: 50
      Lund, Sweden, 221 85
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      Completed
      Site: 33
      Hamburg, Germany, 20253
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      Completed
      Site: 61
      Swansea, United Kingdom, SA6 6NL
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      Completed
      Site: 52
      Uppsala, Sweden, 751 85
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      Completed
      Site: 36
      Koblenz, Germany, 56068
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      Completed
      Site: 32
      Bad Ems, Germany, 56130
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      Completed
      Site: 31
      Trier, Germany, 54290
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      Completed
      Site: 42
      Alzira-Valencia, Spain, 46600
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      Completed
      Site: 60
      Sheffield, United Kingdom, S10 2JF
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      Completed
      Site: 35
      Frankfurt, Germany, 60326
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      Completed
      Site: 55
      Gotenburg, Sweden, 413 45
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      Completed
      Site: 40
      Madrid, Spain, 28046
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      Completed
      Site: 34
      Hagenow, Germany, 19230
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      Completed
      Site: 23
      Usti nad Labem, Czech Republic, 401 13
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      Completed
      Site: 63
      London, United Kingdom, W1P 7PN
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      Completed
      Site: 13
      Edegem, Belgium, 2650
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      Completed
      Site: 10
      Leuven, Belgium, 3000
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      Completed
      Site: 62
      London, United Kingdom, N19 5LW
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      Completed
      Site: 22
      Prague, Czech Republic, 128 08
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      Completed
      Site: 24
      Prague, Czech Republic, 140 59
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      Completed
      Site: 30
      Emmendingen, Germany, 79312
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      Completed
      Site: 12
      Brussels, Belgium, 1090
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      Completed
      Site: 51
      Stockholm, Sweden, 141 86
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      Completed
      Site: 53
      Linkoping, Sweden, 582 24
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      Trial info
      Follow Trial
      Age
      18+ years
      Diamond icon
      Condition
    • Overactive Bladder Disease
      • Gender icon
      Sex
      Female & Male
      Calendar icon
      Trial Dates
      Apr 2004 - Jan 2005
      Additional Study Details
      Inclusion Criteria

        Inclusion Criteria:

      • Patient is willing and able to complete the micturition diary correctly.
      • Symptoms of overactive bladder (urinary frequency and urgency with or without incontinence) for ≥ 3 months

        • At randomization:

      • Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
      • Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period

        • Exclusion Criteria:

      • Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants, contraceptive patches and injectable contraceptives
      • Clinically significant outflow obstruction (at the discretion of the investigator)
      • Significant post void residual volume (PVR>200ml)
      • Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator (for female patients confirmed by a cough provocation test)
      • Patients with a neurological cause for abnormal detrusor activity
      • Diabetic neuropathy
      • Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
      • Uncontrolled narrow angle glaucoma, urinary or gastric retention, colitis ulcerosa, toxic megacolon, myasthenia gravis or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
      • Non-drug treatment including electrostimulation therapy

        • (a bladder training program or pelvic floor exercises which started more than 1 month prior to entry into the study can be continued)

      • Use of medications intended to treat urinary incontinence or listed in Appendix 1 Part A. Part B lists medications that are restricted but accepted under certain conditions
      • Known or suspected hypersensitivity to tolterodine, other anticholinergics, ß-adrenoceptor agonists, or lactose or any of the other inactive ingredients
      • Any clinically significant cardiovascular complication including CVA, recent myocardial infarction and uncontrolled hypertension, indicated by a sitting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg
      • Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
      • Participation in any clinical trial within 30 (90 in the UK) days prior to randomization
      • Employees of the sponsor, third parties associated with the study, or the study site

        • At randomization:

      • Patient who did not complete the micturition diary according to the instructions
      • Average total daily urine volume > 3000 ml as recorded in the micturition diary
      • Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 mmol/L, ASAT or ALAT > 2x upper limit of normal range (ULN), γ-GT > 3x ULN and/or abnormal serum total bilirubin (as assessed in visit 1 samples or alternative sampling within 4 weeks prior to visit 1)

      Frequently Asked Questions

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      Should I be worried about getting a placebo?

      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

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