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

7 maart 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

200

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • 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
  • Verenigde Staten
    • Arizona
      • Tuscon, Arizona, Verenigde Staten, 85712
    • California
      • Atherton, California, Verenigde Staten, 94027
      • Culver City, California, Verenigde Staten, 90232
      • Fresno, California, Verenigde Staten, 93720
      • San Diego, California, Verenigde Staten, 92103
      • Torrance, California, Verenigde Staten, 90505
    • Connecticut
      • Middlebury, Connecticut, Verenigde Staten, 06762
    • Florida
      • Tallahassee, Florida, Verenigde Staten, 32308
    • Iowa
      • Des Moines, Iowa, Verenigde Staten, 50309
    • Louisiana
      • Shreveport, Louisiana, Verenigde Staten, 71106
    • Massachusetts
      • Watertown, Massachusetts, Verenigde Staten, 02472
    • New York
      • Garden City, New York, Verenigde Staten, 11530
    • North Carolina
      • Winston Salem, North Carolina, Verenigde Staten, 27103
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45212
    • Virginia
      • Virginia Beach, Virginia, Verenigde Staten, 23454

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

45 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
Geneesmiddel: Placebo
mondeling
Experimenteel: Mirabegron 50 mg
Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
Geneesmiddel: Mirabegron
oraal
Andere namen:
  • YM178
  • Myrbetriq
Experimenteel: Mirabegron 100 mg
Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
Geneesmiddel: Mirabegron
oraal
Andere namen:
  • YM178
  • Myrbetriq

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Astellas Pharma Inc

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2006

Primaire voltooiing (Werkelijk)

1 augustus 2008

Studie voltooiing (Werkelijk)

1 augustus 2008

Studieregistratiedata

Eerst ingediend

12 december 2006

Eerst ingediend dat voldeed aan de QC-criteria

12 december 2006

Eerst geplaatst (Schatting)

13 december 2006

Updates van studierecords

Laatste update geplaatst (Schatting)

4 april 2014

Laatste update ingediend die voldeed aan QC-criteria

7 maart 2014

Laatst geverifieerd

1 september 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 178-CL-060

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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