Clinical trial NCT01018511: Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
Official title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: EC905
Solifenacin succinate
Tamsulosin hydrochloride OCAS
Treatment
Benign Prostatic Hyperplasia
Vesomni
Lower Urinary Tract Symptoms
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 1334
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.


Eligibility criteria: Inclusion Criteria:

* Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months
* A total International Prostate Symptom Score (IPSS) of ≥13
* A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow
* A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)

Exclusion Criteria:

* Any significant Post Void Residual volume (\>150 mL)
* A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal ultrasound
* Evidence of a symptomatic urinary tract infection

Primary outcomes:
measure: Change From Baseline to End of Treatment in Total International Prostate Symptom Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in IPSS Voiding Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in IPSS Storage Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in IPSS QoL Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Individual IPSS Scores
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Symptom Bother Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in HRQoL Subscale: Social Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in HRQoL Subscale: Total Score
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Were OAB-q Responders at End of Treatment
timeFrame: Week 12 (end of treatment)
measure: Change From Baseline to End of Treatment in EQ-5D Mobility Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in EQ-5D Self-care Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
timeFrame: Baseline and Week 12
measure: Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms
timeFrame: Baseline and Week 12
measure: Patient Global Impression Scale at End of Treatment: General Health
timeFrame: Baseline and Week 12
measure: Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms
timeFrame: Baseline and Week 12
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)
measure: Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
timeFrame: Baseline and Week 12
measure: Apparent Clearance (CL/F) of Tamsulosin
timeFrame: Week 4, Week 8 and Week 12
measure: Maximum Concentration at Steady State (Cmaxss) of Tamsulosin
timeFrame: Week 4, Week 8 and Week 12
measure: Minimum Concentration at Steady State (Cminss) of Tamsulosin
timeFrame: Week 4, Week 8 and Week 12
measure: Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin
timeFrame: Week 4, Week 8 and Week 12
measure: Area Under the Curve at Steady State (AUCss) of Tamsulosin
timeFrame: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)
measure: CL/F of Solifenacin
timeFrame: Week 4, Week 8 and Week 12
measure: Cmaxss of Solifenacin
timeFrame: Week 4, Week 8 and Week 12
measure: Cminss of Solifenacin
timeFrame: Week 4, Week 8 and Week 12
measure: Tmaxss of Solifenacin
timeFrame: Week 4, Week 8 and Week 12
measure: AUCss of Solifenacin
timeFrame: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Salzburg
country: Austria
city: Vienna
country: Austria
city: Minsk
country: Belarus
city: Minsk
country: Belarus
city: Minsk
country: Belarus
city: Antwerp
country: Belgium
city: Antwerp
country: Belgium
city: Assebroek
country: Belgium
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Liege 1
country: Belgium
city: Sint-Truiden
country: Belgium
city: Turnhout
country: Belgium
city: Hradec Kralove
country: Czechia
city: Ostrava
country: Czechia
city: Plzen
country: Czechia
city: Prague
country: Czechia
city: Roudnice nad Labem
country: Czechia
city: Uherske Hradiste
country: Czechia
city: Usti nad Labem
country: Czechia
city: Zdar nad Sazavou
country: Czechia
city: Aix en Provence
country: France
city: Angers
country: France
city: Bordeaux Cedex
country: France
city: Colmar Cedex
country: France
city: Dijon
country: France
city: Dijon
country: France
city: Lyon Cedex 3
country: France
city: Montlucon
country: France
city: Orleans Cedex 2
country: France
city: Paris Cedex 10
country: France
city: Paris Cedex 14
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Rennes
country: France
city: Tours Cedex
country: France
city: Bad Ems
country: Germany
city: Bautzen
country: Germany
city: Frankfurt
country: Germany
city: Hagenow
country: Germany
city: Halle Saale
country: Germany
city: Hamburg
country: Germany
city: Henningsdorf
country: Germany
city: Hettstedt
country: Germany
city: Koblenz
country: Germany
city: Leipzig
country: Germany
city: Leipzig
country: Germany
city: Lutherstadt Eisleben
country: Germany
city: Neustadt in Sachsen
country: Germany
city: Uetersen
country: Germany
city: Budapest
country: Hungary
city: Kormend
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Sopron
country: Hungary
city: Szekszard
country: Hungary
city: Szentes
country: Hungary
city: Tatabanya
country: Hungary
city: Avellino
country: Italy
city: Bari
country: Italy
city: Bergamo
country: Italy
city: Catania
country: Italy
city: Catanzaro
country: Italy
city: Florence
country: Italy
city: Palermo
country: Italy
city: Treviglio
country: Italy
city: Turin
country: Italy
city: Amsterdam
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Doetinchem
country: Netherlands
city: Eindhoven
country: Netherlands
city: Etten-Leur
country: Netherlands
city: Maastricht
country: Netherlands
city: Sneek
country: Netherlands
city: Sneek
country: Netherlands
city: Tilburg
country: Netherlands
city: Winterswijk
country: Netherlands
city: Bielsko Biala
country: Poland
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Pulawy
country: Poland
city: Warsaw
country: Poland
city: Wiecbork
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Nitra
country: Slovakia
city: Piestany
country: Slovakia
city: Presov
country: Slovakia
city: Skalica
country: Slovakia
city: Trencin
country: Slovakia
city: Zilina
country: Slovakia
city: Birmingham
country: United Kingdom
city: Bristol
country: United Kingdom
city: Bristol
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Chorley
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Manchester
country: United Kingdom
city: Northwood
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Reading
country: United Kingdom
city: Reading
country: United Kingdom
city: Reading
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Taunton
country: United Kingdom
city: Torquay
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3.