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Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms (Neptune)

Primary Purpose

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo tamsulosin hydrochloride OCAS 0.4 mg
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
tamsulosin hydrochloride OCAS 0.4 mg
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
Sponsored by
Astellas Pharma Europe B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring EC905, Solifenacin succinate, Tamsulosin hydrochloride OCAS, Treatment, Benign Prostatic Hyperplasia, Vesomni, Lower Urinary Tract Symptoms

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Arm Label

Placebo

TOCAS 0.4 mg

FDC 0.4 mg/6 mg

FDC 0.4 mg/9 mg

Arm Description

Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet

Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet

Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet

Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet

Outcomes

Primary Outcome Measures

Change From Baseline to End of Treatment in Total International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: Incomplete emptying of the bladder Intermittency Weak stream Hesitancy Frequency Urgency Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])
The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.

Secondary Outcome Measures

Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
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.
Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. 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.
Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Change From Baseline to End of Treatment in IPSS Voiding Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. 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 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).
Change From Baseline to End of Treatment in IPSS Storage Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on 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 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).
Change From Baseline to End of Treatment in IPSS QoL Score
The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).
Change From Baseline to End of Treatment in Individual IPSS Scores
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: Incomplete emptying of the bladder Intermittency Weak stream Hesitancy Frequency Urgency Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom.
Change From Baseline to End of Treatment in Symptom Bother Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.
Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping concern sleep social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping concern sleep social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping concern sleep social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Change From Baseline to End of Treatment in HRQoL Subscale: Social Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping concern sleep social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Change From Baseline to End of Treatment in HRQoL Subscale: Total Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping concern sleep social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Percentage of Participants Who Were OAB-q Responders at End of Treatment
A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.
Change From Baseline to End of Treatment in EQ-5D Mobility Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: mobility self-care usual activity pain/discomfort anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).
Change From Baseline to End of Treatment in EQ-5D Self-care Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: mobility self-care usual activity pain/discomfort anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: mobility self-care usual activity pain/discomfort anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: mobility self-care usual activity pain/discomfort anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: mobility self-care usual activity pain/discomfort anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).
Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).
Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms
The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
Patient Global Impression Scale at End of Treatment: General Health
The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms
The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
Number of Participants With Adverse Events (AEs)
Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) 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 (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug.
Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Qmax during a micturition (urination) was recorded using uroflowmetry.
Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
Qmean during a micturition (urination) was recorded using uroflowmetry.
Apparent Clearance (CL/F) of Tamsulosin
Maximum Concentration at Steady State (Cmaxss) of Tamsulosin
Minimum Concentration at Steady State (Cminss) of Tamsulosin
Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin
Area Under the Curve at Steady State (AUCss) of Tamsulosin
CL/F of Solifenacin
Cmaxss of Solifenacin
Cminss of Solifenacin
Tmaxss of Solifenacin
AUCss of Solifenacin

Full Information

First Posted
November 19, 2009
Last Updated
February 15, 2017
Sponsor
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01018511
Brief Title
Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
Acronym
Neptune
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Keywords
EC905, Solifenacin succinate, Tamsulosin hydrochloride OCAS, Treatment, Benign Prostatic Hyperplasia, Vesomni, Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Arm Title
TOCAS 0.4 mg
Arm Type
Active Comparator
Arm Description
Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Arm Title
FDC 0.4 mg/6 mg
Arm Type
Experimental
Arm Description
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Arm Title
FDC 0.4 mg/9 mg
Arm Type
Experimental
Arm Description
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo tamsulosin hydrochloride OCAS 0.4 mg
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
tamsulosin hydrochloride OCAS 0.4 mg
Other Intervention Name(s)
Harnal ®, Omnic®, Flomax®, YM617
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
Other Intervention Name(s)
Vesomni, EC905
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
Other Intervention Name(s)
EC905
Intervention Description
tablet
Primary Outcome Measure Information:
Title
Change From Baseline to End of Treatment in Total International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: Incomplete emptying of the bladder Intermittency Weak stream Hesitancy Frequency Urgency Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])
Description
The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
Description
A micturition is any voluntary urination, excluding episodes of incontinence only. 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.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
Description
A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
Description
An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Description
An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Description
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
Description
A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
Description
The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in IPSS Voiding Score
Description
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. 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 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in IPSS Storage Score
Description
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on 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 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in IPSS QoL Score
Description
The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Individual IPSS Scores
Description
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: Incomplete emptying of the bladder Intermittency Weak stream Hesitancy Frequency Urgency Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Symptom Bother Score
Description
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score
Description
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping concern sleep social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score
Description
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping concern sleep social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score
Description
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping concern sleep social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in HRQoL Subscale: Social Score
Description
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping concern sleep social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in HRQoL Subscale: Total Score
Description
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping concern sleep social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Who Were OAB-q Responders at End of Treatment
Description
A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.
Time Frame
Week 12 (end of treatment)
Title
Change From Baseline to End of Treatment in EQ-5D Mobility Score
Description
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: mobility self-care usual activity pain/discomfort anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in EQ-5D Self-care Score
Description
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: mobility self-care usual activity pain/discomfort anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
Description
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: mobility self-care usual activity pain/discomfort anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
Description
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: mobility self-care usual activity pain/discomfort anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
Description
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: mobility self-care usual activity pain/discomfort anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
Description
Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).
Time Frame
Baseline and Week 12
Title
Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms
Description
The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
Time Frame
Baseline and Week 12
Title
Patient Global Impression Scale at End of Treatment: General Health
Description
The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
Time Frame
Baseline and Week 12
Title
Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms
Description
The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
Time Frame
Baseline and Week 12
Title
Number of Participants With Adverse Events (AEs)
Description
Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) 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 (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug.
Time Frame
From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)
Title
Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
Description
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Description
Qmax during a micturition (urination) was recorded using uroflowmetry.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
Description
Qmean during a micturition (urination) was recorded using uroflowmetry.
Time Frame
Baseline and Week 12
Title
Apparent Clearance (CL/F) of Tamsulosin
Time Frame
Week 4, Week 8 and Week 12
Title
Maximum Concentration at Steady State (Cmaxss) of Tamsulosin
Time Frame
Week 4, Week 8 and Week 12
Title
Minimum Concentration at Steady State (Cminss) of Tamsulosin
Time Frame
Week 4, Week 8 and Week 12
Title
Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin
Time Frame
Week 4, Week 8 and Week 12
Title
Area Under the Curve at Steady State (AUCss) of Tamsulosin
Time Frame
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)
Title
CL/F of Solifenacin
Time Frame
Week 4, Week 8 and Week 12
Title
Cmaxss of Solifenacin
Time Frame
Week 4, Week 8 and Week 12
Title
Cminss of Solifenacin
Time Frame
Week 4, Week 8 and Week 12
Title
Tmaxss of Solifenacin
Time Frame
Week 4, Week 8 and Week 12
Title
AUCss of Solifenacin
Time Frame
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Chair
Facility Information:
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Vienna
ZIP/Postal Code
1090
Country
Austria
City
Minsk
ZIP/Postal Code
220036
Country
Belarus
City
Minsk
ZIP/Postal Code
220114
Country
Belarus
City
Minsk
ZIP/Postal Code
220119
Country
Belarus
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
City
Antwerp
ZIP/Postal Code
2030
Country
Belgium
City
Assebroek
ZIP/Postal Code
8310
Country
Belgium
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege 1
ZIP/Postal Code
4000
Country
Belgium
City
Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
700 30
Country
Czech Republic
City
Plzen
ZIP/Postal Code
301 24
Country
Czech Republic
City
Prague
ZIP/Postal Code
180 81
Country
Czech Republic
City
Roudnice nad Labem
ZIP/Postal Code
413 01
Country
Czech Republic
City
Uherske Hradiste
ZIP/Postal Code
686 08
Country
Czech Republic
City
Usti nad Labem
ZIP/Postal Code
40001
Country
Czech Republic
City
Zdar nad Sazavou
ZIP/Postal Code
591 01
Country
Czech Republic
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
City
Angers
ZIP/Postal Code
49033
Country
France
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
City
Colmar Cedex
ZIP/Postal Code
68024
Country
France
City
Dijon
ZIP/Postal Code
21000
Country
France
City
Dijon
ZIP/Postal Code
21079
Country
France
City
Lyon Cedex 3
ZIP/Postal Code
69437
Country
France
City
Montlucon
ZIP/Postal Code
03100
Country
France
City
Orleans Cedex 2
ZIP/Postal Code
45067
Country
France
City
Paris Cedex 10
ZIP/Postal Code
75020
Country
France
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
City
Paris
ZIP/Postal Code
75010
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Tours Cedex
ZIP/Postal Code
37044
Country
France
City
Bad Ems
ZIP/Postal Code
56130
Country
Germany
City
Bautzen
ZIP/Postal Code
02625
Country
Germany
City
Frankfurt
ZIP/Postal Code
65933
Country
Germany
City
Hagenow
ZIP/Postal Code
19230
Country
Germany
City
Halle Saale
ZIP/Postal Code
06132
Country
Germany
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
City
Henningsdorf
ZIP/Postal Code
16761
Country
Germany
City
Hettstedt
ZIP/Postal Code
06333
Country
Germany
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
City
Leipzig
ZIP/Postal Code
04105
Country
Germany
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
City
Lutherstadt Eisleben
ZIP/Postal Code
06295
Country
Germany
City
Neustadt in Sachsen
ZIP/Postal Code
01844
Country
Germany
City
Uetersen
ZIP/Postal Code
25436
Country
Germany
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
City
Kormend
ZIP/Postal Code
9900
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
City
Szentes
ZIP/Postal Code
6601
Country
Hungary
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
City
Avellino
ZIP/Postal Code
83100
Country
Italy
City
Bari
ZIP/Postal Code
70124
Country
Italy
City
Bergamo
ZIP/Postal Code
24125
Country
Italy
City
Catania
ZIP/Postal Code
95124
Country
Italy
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
City
Florence
ZIP/Postal Code
50139
Country
Italy
City
Palermo
ZIP/Postal Code
90146
Country
Italy
City
Treviglio
ZIP/Postal Code
24047
Country
Italy
City
Turin
ZIP/Postal Code
10154
Country
Italy
City
Amsterdam
ZIP/Postal Code
1100 AD
Country
Netherlands
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
City
Doetinchem
ZIP/Postal Code
7009 BL
Country
Netherlands
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
City
Etten-Leur
ZIP/Postal Code
4872 LA
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
City
Sneek
ZIP/Postal Code
8600 BA
Country
Netherlands
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
City
Winterswijk
ZIP/Postal Code
7101 BN
Country
Netherlands
City
Bielsko Biala
ZIP/Postal Code
43-300
Country
Poland
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland
City
Wiecbork
ZIP/Postal Code
89-410
Country
Poland
City
Moscow
ZIP/Postal Code
111020
Country
Russian Federation
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125206
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
198013
Country
Russian Federation
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
City
Skalica
ZIP/Postal Code
909 82
Country
Slovakia
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
City
Zilina
Country
Slovakia
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G81 2DR
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
City
Reading
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
City
Reading
ZIP/Postal Code
RG2 7AG
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
Citations:
PubMed Identifier
23932438
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.
Results Reference
background
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=38
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms

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