Storage and Voiding Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) MedDRA version: 9.1 Level: LLT Classification code 10027561 Term: Micturition disorder MedDRA version: 9.1 Level: LLT Classification code 10005053 Term: Bladder neck obstruction
Conditions
Interventions
Trade Name: OMNIC TOCAS 0,4
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TAMSULOSIN HYDROCHLORIDE
CAS Number: 106463176
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Astellas Pharma US, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male subject and is at least 45 years of age. - Institutional Review Board (IRB)-approved written Informed Consent and HIPAA Authorization for U.S. sites, or equivalent privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures including withdrawal of prohibited medication. - Willing and able to complete the 3-day micturition diary and questionnaires correctly. - Voiding and storage lower urinary tract symptoms for at least 3 months. - Total IPSS (International Prostate Symptom Score) = 8. - Bladder Outlet Obstruction (BOO) indicated by a Bladder Outlet Obstruction Index (BOOI) = 20. - Maximum urinary flow rate of = 12 mL/sec, with a voided volume of =120 mL during free flow in a representative assessment. 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: - History of urinary retention in the preceding 12 months. - Current urinary tract infection (UTI) or symptomatic and recurrent UTI of > 3 episodes within 12 months. - History or diagnosis of any of the following urinary conditions: Chronic inflammation such as chronic prostatitis, Stone in bladder or ureter, Other causes of outflow tract obstruction, such as bladder neck stenosis and urethral strictures. - Diagnosis or history of carcinoma (including prostate cancer) or previous pelvic radiation therapy, except non metastatic basal or squamous cell carcinoma of the skin that had been treated successfully - Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1 - Total daily urine volume > 3000 mL as verified in the 3-day micturition diary at Baseline - Renal or hepatic impairment (2 X ULN values in any parameters and considered clinically significant by the Investigator) as indicated on screening laboratory results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the urodynamic variables of male subjects with LUTS and BOO treated with the co-administration of 6 mg solifenacin succinate and TOCAS, and 9 mg solifenacin succinate and tamsulosin OCAS versus placebo.;Secondary Objective: To evaluate the tolerability and safety of the co-administration of 2 doses of solifenacin succinate and tamsulosin OCAS in male subjects with LUTS and BOO. To compare the efficacy of the co-administration of 2 doses of solifenacin succinate and tamsulosin OCAS versus placebo in signs and symptoms of BPH in male subjects with LUTS and BOO ;Primary end point(s): The primary variables are urodynamic variables: - Change from baseline to end of treatment in detrusor pressure (Pdet) at maximum flow rate (Qmax) (PdetQmax) - Change from baseline to end of treatment in maximum flow rate (Qmax) | — |
Countries
Belgium, Czech Republic, Germany, Hungary
Outcome results
None listed