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

7 marzo 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

200

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

45 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
Droga: Placebo
orale
Sperimentale: Mirabegron 50 mg
Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
Droga: Mirabegron
orale
Altri nomi:
  • YM178
  • Myrbetriq
Sperimentale: Mirabegron 100 mg
Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
Droga: Mirabegron
orale
Altri nomi:
  • YM178
  • Myrbetriq

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Astellas Pharma Inc

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2006

Completamento primario (Effettivo)

1 agosto 2008

Completamento dello studio (Effettivo)

1 agosto 2008

Date di iscrizione allo studio

Primo inviato

12 dicembre 2006

Primo inviato che soddisfa i criteri di controllo qualità

12 dicembre 2006

Primo Inserito (Stima)

13 dicembre 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 aprile 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 marzo 2014

Ultimo verificato

1 settembre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 178-CL-060

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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