Overactive bladder MedDRA version: 8.1 Level: LLT Classification code 10059617
Conditions
Interventions
Product Code: YM178
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: YM178
Other
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged = 18 years. 2. Signed informed consent has been obtained. 3. Patient is willing and able to complete the micturition diary and questionnaires correctly. 4. Symptoms of overactive bladder (urinary frequency and urgency with or without incontinence) for = 3 months. At randomization: 5. Patient must experience frequency of micturition on average = 8 times per 24-hour period during the 3-day micturition diary period. 6. Patient must experience at least 3 episodes of urgency with or without incontinence (grade 3 or 4), during the 3-day micturition diary period. 7. Patient 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
Exclusion criteria: At study entry 1. Breastfeading women, pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and not practicing a highly reliable method of birth control (these are methods with a failure quotient of 200ml). 4. 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). 5. Patients with indwelling catheters or practicing intermittent self-catheterization. 6. Diabetic neuropathy. 7. 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. 8. 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. 9. 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). 10. 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). 11. Known or suspected hypersensitivity to tolterodine, other anticholinergics, ß-AR agonists, or lactose or any of the other inactive ingredients. 12. Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to visit 1, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, sinus tachycardia, heart failure (NYHA class II/IV), orthostatic hypotension, stroke and uncontrolled hypertension, indicated by a sitting systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg. In addition patients with a heart rate 100 should be excluded. 13. Any other clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the study. 14. Participation in any clinical study within 30 (90 in the UK) days prior to randomization. 15. Employees of the Astellas Group, third parties associated with the study, or the study site. At randomization: 16. Patient who did not complete the micturition diary according to the instructions. 17. Average total daily urine volume > 3000 ml as recorded in the micturition diary. 18. Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 mmol/L, AST or ALT > 2x upper limit of n
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose-response relationship of YM178-OCAS on efficacy in patients with OAB; Secondary Objective: - To evaluate the safety and tolerability of once daily dosing with YM178-OCAS in patients with OAB. - To compare the efficacy of YM178-OCAS to tolterodine 4 mg qd. - To compare the safety and tolerability of YM178-OCAS to tolterodine 4 mg qd. - To collect population pharmacokinetics data in patients with OAB. ; Primary end point(s): Primary Endpoint Change from baseline to endpoint in mean number of micturitions/24 h | — |
Countries
Belgium, Czech Republic, Denmark, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed