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A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

7 марта 2014 г. обновлено: Astellas Pharma Inc

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)

This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

200

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Канада
    • British Columbia
      • Victoria, British Columbia, Канада, V8T 5G1
      • Victoria, British Columbia, Канада, V8V 3N1
    • Manitoba
      • Winnipeg, Manitoba, Канада, R3A 1R9
    • New Brunswick
      • St John, New Brunswick, Канада, E2L 378
    • Nova Scotia
      • Halifax, Nova Scotia, Канада, B3H 3A7
    • Ontario
      • Kitchener, Ontario, Канада, N2N 2B9
      • Toronto, Ontario, Канада, M4N 3M5
    • Quebec
      • Chicoutimi, Quebec, Канада
      • Chicoutimi, Quebec, Канада, G7F 4A3
      • Montreal, Quebec, Канада, H3T 1E2
      • Pointe-Claire, Quebec, Канада, H9R 4S3
      • Sherbrooke, Quebec, Канада, J1H 5N4
  • Соединенные Штаты
    • Arizona
      • Tuscon, Arizona, Соединенные Штаты, 85712
    • California
      • Atherton, California, Соединенные Штаты, 94027
      • Culver City, California, Соединенные Штаты, 90232
      • Fresno, California, Соединенные Штаты, 93720
      • San Diego, California, Соединенные Штаты, 92103
      • Torrance, California, Соединенные Штаты, 90505
    • Connecticut
      • Middlebury, Connecticut, Соединенные Штаты, 06762
    • Florida
      • Tallahassee, Florida, Соединенные Штаты, 32308
    • Iowa
      • Des Moines, Iowa, Соединенные Штаты, 50309
    • Louisiana
      • Shreveport, Louisiana, Соединенные Штаты, 71106
    • Massachusetts
      • Watertown, Massachusetts, Соединенные Штаты, 02472
    • New York
      • Garden City, New York, Соединенные Штаты, 11530
    • North Carolina
      • Winston Salem, North Carolina, Соединенные Штаты, 27103
    • Ohio
      • Cincinnati, Ohio, Соединенные Штаты, 45212
    • Virginia
      • Virginia Beach, Virginia, Соединенные Штаты, 23454

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

45 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Мужской

Описание

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)

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Placebo
Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
Лекарство: Плацебо
устный
Экспериментальный: Mirabegron 50 mg
Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
Лекарство: Мирабегрон
устный
Другие имена:
  • YM178
  • Мирбетрик
Экспериментальный: Mirabegron 100 mg
Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
Лекарство: Мирабегрон
устный
Другие имена:
  • YM178
  • Мирбетрик

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Временное ограничение: Baseline and Week 12

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
Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
Временное ограничение: Baseline and Week 12

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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
Временное ограничение: Baseline and Week 12

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
Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)
Временное ограничение: Baseline and Week 12

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
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)
Временное ограничение: Baseline and Weeks 1, 4, 8 and 12

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
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Временное ограничение: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
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.
From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score
Временное ограничение: Baseline and Weeks 1, 4, 8 and 12

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
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score
Временное ограничение: Baseline and Weeks 1, 4, 8 and 12

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
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score
Временное ограничение: Baseline and Weeks 1, 4, 8 and 12

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
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)
Временное ограничение: Baseline and Weeks 1, 4, 8 and 12

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
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours
Временное ограничение: Baseline and Weeks 1, 4, 8 and 12

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
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
Временное ограничение: Baseline and Weeks 1, 4, 8 and 12

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
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Временное ограничение: Baseline and Weeks 1, 4, 8 and 12

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
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition
Временное ограничение: Baseline and Weeks 1, 4, 8 and 12

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
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
Временное ограничение: Baseline and Weeks 4, 8 and 12

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
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
Временное ограничение: Baseline and Weeks 4, 8 and 12

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
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
Временное ограничение: Baseline and Weeks 4, 8 and 12

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
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
Временное ограничение: Baseline and Weeks 4, 8 and 12

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Astellas Pharma Inc

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 декабря 2006 г.

Первичное завершение (Действительный)

1 августа 2008 г.

Завершение исследования (Действительный)

1 августа 2008 г.

Даты регистрации исследования

Первый отправленный

12 декабря 2006 г.

Впервые представлено, что соответствует критериям контроля качества

12 декабря 2006 г.

Первый опубликованный (Оценивать)

13 декабря 2006 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

4 апреля 2014 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

7 марта 2014 г.

Последняя проверка

1 сентября 2012 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 178-CL-060

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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