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

2014年3月7日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

200

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

45年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

男

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：Placebo
Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
薬：プラセボ
オーラル
実験的：Mirabegron 50 mg
Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
薬：ミラベグロン
オーラル
他の名前：
  • YM178
  • ミラベトリック
実験的：Mirabegron 100 mg
Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
薬：ミラベグロン
オーラル
他の名前：
  • YM178
  • ミラベトリック

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Astellas Pharma Inc

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2006年12月1日

一次修了 (実際)

2008年8月1日

研究の完了 (実際)

2008年8月1日

試験登録日

最初に提出

2006年12月12日

QC基準を満たした最初の提出物

2006年12月12日

最初の投稿 (見積もり)

2006年12月13日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年4月4日

QC基準を満たした最後の更新が送信されました

2014年3月7日

最終確認日

2012年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 178-CL-060

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