A Randomized, Double-Blind, Parallel Group, Active Controlled, Multicenter Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist YM178 (50 mg qd and 100 mg qd) in Subjects with Symptoms of Overactive Bladder - TAURUS
- Conditions
- Symptoms of overactive bladderMedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder
- Registration Number
- EUCTR2007-001452-39-LT
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2500
Inclusion criteria at Visit 1/screening
1. Male or female subject aged = 18 years.
2. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g. HIPAA Authorization for U.S. sites) is obtained from the subject or legally authorized representative (prior to any study-related procedures; including withdrawal of prohibited medication, if applicable).
3. Subject is willing and able to complete the micturition diary and questionnaires correctly.
4. Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for = 3 months.
Inclusion criteria at Visit 2/baseline
5. Subject experiences frequency of micturition on average = 8 times per 24-hour period during the 3-day micturition diary period.
6. Subject must experience at least 3 episodes of urgency with or without incontinence (grade 3 or 4), during the 3-day micturition diary period.
7. Subject must still fulfill all inclusion criteria and none of the exclusion criteria from Visit 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria at Visit 1/screening
1. Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control (these are methods with a failure quotient of <1% per year such as hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine pessaries restricted to hormone contraceptive coil, sexual abstinence or vasectomy of the partner). The pregnancy test (beta-HCG in serum) at Visit 1 needs to be negative in women of childbearing potential.
2. Subject has clinically significant bladder outflow obstruction at risk of urinary retention (at the discretion of the investigator).
3. Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test (Appendix 4)).
4. Subject has an indwelling catheter or practices intermittent self-catheterization.
5. Subject has diabetic neuropathy.
6. Subject has 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.
7. Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe colitis ulcerosa, toxic megacolon, myasthenia gravis or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contraindicated.
8. Subject receives current non-drug treatment including electro-stimulation therapy (a bladder training program or pelvic floor exercises which started more than 30 days prior to entry into the study can be continued).
9. Subject is using medications intended to treat OAB or prohibited medications listed in Appendix 1 Part A. Subject is excluded if using restricted medications (Appendix 1, Part B) and conditions specified in Appendix 1, Part B are not met.
10. Subject has severe hypertension, which is defined as a sitting average systolic blood pressure = 180 mmHg and/or average diastolic blood pressure = 110 mmHg (see section 5.4.1. Vital Signs).
11. Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other ß-AR agonists, or lactose or any of the other inactive ingredients.
12. Subject has any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study.
13. Subject has been treated with any investigational drug within 30 days (90 in the UK for all clinical studies except 178-CL-046) prior to Visit 1 /screening.
14. Subject is an employee of the Astellas Group, third parties associated with the study, or the clinical study site team.
Exclusion criteria at Visit 2/baseline
15. Subject has an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period.
16. Subject has - in the opinion of the investigator - clinically significant increases in laboratory values as assessed in Visit 1 samples (e.g. serum creatinine >150 umol/L, AST and/or ALT > 2x upper limit of normal range (ULN), or ?-GT > 3x ULN)
17. Subject has an abnormal ECG, which in the opinion of the investigator makes the subject unsuitable for the study.
18. Subject has severe hypertension, which is defined as a sitting average systolic blood pressure = 180 mmHg and/or average diasto
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method