A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study to Evaluate the Urodynamics and Safety of YM178 in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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British Columbia
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Victoria, British Columbia, Kanada, V8T 5G1
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Victoria, British Columbia, Kanada, V8V 3N1
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Manitoba
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Winnipeg, Manitoba, Kanada, R3A 1R9
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New Brunswick
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St John, New Brunswick, Kanada, E2L 378
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 3A7
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Ontario
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Kitchener, Ontario, Kanada, N2N 2B9
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Toronto, Ontario, Kanada, M4N 3M5
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Quebec
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Chicoutimi, Quebec, Kanada
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Chicoutimi, Quebec, Kanada, G7F 4A3
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Montreal, Quebec, Kanada, H3T 1E2
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Pointe-Claire, Quebec, Kanada, H9R 4S3
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Sherbrooke, Quebec, Kanada, J1H 5N4
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Arizona
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Tuscon, Arizona, Spojené státy, 85712
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California
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Atherton, California, Spojené státy, 94027
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Culver City, California, Spojené státy, 90232
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Fresno, California, Spojené státy, 93720
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San Diego, California, Spojené státy, 92103
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Torrance, California, Spojené státy, 90505
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Connecticut
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Middlebury, Connecticut, Spojené státy, 06762
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Florida
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Tallahassee, Florida, Spojené státy, 32308
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Iowa
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Des Moines, Iowa, Spojené státy, 50309
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Louisiana
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Shreveport, Louisiana, Spojené státy, 71106
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Massachusetts
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Watertown, Massachusetts, Spojené státy, 02472
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New York
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Garden City, New York, Spojené státy, 11530
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North Carolina
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Winston Salem, North Carolina, Spojené státy, 27103
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Ohio
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Cincinnati, Ohio, Spojené státy, 45212
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Virginia
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Virginia Beach, Virginia, Spojené státy, 23454
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Men 45 years of age or older
- Documented bladder outlet obstruction
Exclusion Criteria:
- History of urinary retention
- Symptomatic and recurrent urinary tract infection (UTI)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Komparátor placeba: Placebo
Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
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ústní
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Experimentální: Mirabegron 50 mg
Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
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ústní
Ostatní jména:
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Experimentální: Mirabegron 100 mg
Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
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ústní
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Časové okno: Baseline and Week 12
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Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation. Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Week 12
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Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
Časové okno: Baseline and Week 12
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Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation. Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Week 12
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
Časové okno: Baseline and Week 12
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The Bladder Contractile Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula: BCI = pdetQmax + 5Qmax. Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Week 12
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Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)
Časové okno: Baseline and Week 12
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Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula: Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity. A higher number indicates a higher voiding efficiency. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Week 12
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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)
Časové okno: Baseline and Weeks 1, 4, 8 and 12
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Healthy micturitions (urinations) result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding and was assessed using abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 1, 4, 8 and 12
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Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Časové okno: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
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Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant.
A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.
AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.
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From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score
Časové okno: Baseline and Weeks 1, 4, 8 and 12
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The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 1, 4, 8 and 12
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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score
Časové okno: Baseline and Weeks 1, 4, 8 and 12
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The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 1, 4, 8 and 12
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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score
Časové okno: Baseline and Weeks 1, 4, 8 and 12
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The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 1, 4, 8 and 12
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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)
Časové okno: Baseline and Weeks 1, 4, 8 and 12
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The patient perception of bladder condition (PPBC) asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 1, 4, 8 and 12
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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours
Časové okno: Baseline and Weeks 1, 4, 8 and 12
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A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 1, 4, 8 and 12
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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours
Časové okno: Baseline and Weeks 1, 4, 8 and 12
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For each micturition and/or incontinence episode in the 3 days preceding the clinic visit, participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild Urgency, could postpone passing water for as long as necessary; 2: Moderate Urgency, could postpone passing water for a short while; 3: Severe Urgency, could not postpone passing water; 4: Urge Incontinence, leaked before reaching the toilet. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 1, 4, 8 and 12
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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Časové okno: Baseline and Weeks 1, 4, 8 and 12
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The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 1, 4, 8 and 12
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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition
Časové okno: Baseline and Weeks 1, 4, 8 and 12
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The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 1, 4, 8 and 12
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Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
Časové okno: Baseline and Weeks 4, 8 and 12
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Male lower urinary tract symptoms were assessed by the ICIQ MaleLUTS questionnaire which consists of 13 questions each on a 0-4 scale (larger scores correspond to worse conditions). The total symptom score ranges from 0 to 52. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 4, 8 and 12
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Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score
Časové okno: Baseline and Weeks 4, 8 and 12
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The degree to which urinary symptoms bothered participants was assessed by the ICIQ MaleLUTS questionnaire which consists of 13 symptom bother questions each on a 0-10 scale (larger scores correspond to worse outcomes). The total bother score ranges from 0 to 130. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 4, 8 and 12
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Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
Časové okno: Baseline and Weeks 4, 8 and 12
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Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions each on a 1-4 scale (larger scores correspond to less quality of life). The total symptom score ranges from 19 - 76. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 4, 8 and 12
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Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score
Časové okno: Baseline and Weeks 4, 8 and 12
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Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate. |
Baseline and Weeks 4, 8 and 12
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urologická onemocnění
- Onemocnění močového měchýře
- Urologické projevy
- Uretrální onemocnění
- Uretrální obstrukce
- Příznaky dolních močových cest
- Obstrukce krku močového měchýře
- Fyziologické účinky léků
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Urologická činidla
- Adrenergní agonisté
- Adrenergní beta-agonisté
- Agonisté adrenergních beta-3 receptorů
- Mirabegron
Další identifikační čísla studie
- 178-CL-060
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