A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center 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: 14.1Level: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disorders
- Registration Number
- EUCTR2007-001452-39-IT
- Lead Sponsor
- Astellas Pharma B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2500
Subject is eligible for the study if all of the following apply:
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 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: 0
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
Subject will be excluded from participation if any of the following apply:
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 (β-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 selfcatheterization.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 a known or suspected hypersensitivity to tolterodine, other
anticholinergics, YM178, other ß-AR agonists, or lactose or any of the other
inactive ingredients.
11. Subject has any clinically significant condition, which in the opinion of the
investigator makes the subject unsuitable for the study.
12. 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.
13. 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
14. Subject has an average total daily urine volume > 3000 mL as recorded in
the 3-day micturition diary period.
15. 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 γ-GT > 3x ULN)
16. Subject has an abnormal ECG, which in the opinion of the investigator
makes the subject unsuitable for the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety and tolerability of long-term treatment with YM178 (50 mg<br>qd and 100 mg qd) in subjects with symptoms of overactive bladder.;Secondary Objective: To assess the efficacy of long-term treatment with YM178 (50 mg qd and 100<br>mg qd) in subjects with symptoms of overactive bladder.<br>To compare the long-term safety and efficacy of YM178 with tolterodine ER 4<br>mg qd in the treatment of subjects with symptoms of overactive bladder.;Primary end point(s): Incidence and severity of adverse events.
- Secondary Outcome Measures
Name Time Method