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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
178-CL-008
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
N/A
Product
YM178
tolterodine
Placebo
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment number
260
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Study documents

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

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    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
    • 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
    MaximizeExclusion 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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    While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

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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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