Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms (Neptune II)
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| ClinicalTrials.gov Identifier: NCT01021332 |
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Recruitment Status :
Completed
First Posted : November 26, 2009
Results First Posted : January 22, 2016
Last Update Posted : December 18, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia | Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1067 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component |
| Actual Study Start Date : | April 26, 2010 |
| Actual Primary Completion Date : | December 14, 2011 |
| Actual Study Completion Date : | December 14, 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Total Group
Participants who received at least one dose of open-label fixed dose combination (FDC) treatment
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Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
oral
Other Names:
Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg) oral
Other Name: EC905 |
- Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks) ]Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (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 the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).
- Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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) [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]Qmax during a micturition (urination) was recorded using uroflowmetry.
- Change From Baseline to End of Treatment in Average Flow Rate (Qmean) [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]Qmean during a micturition (urination) was recorded using uroflowmetry.
- Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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]) [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 TUS/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.
- Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 Quality of Life (QoL) Score [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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 Quality of Life (HRQoL) Subscale: Coping Score [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 Health-related Quality of Life (HRQoL) Subscale: Concern Score [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 Health-related Quality of Life (HRQoL) Subscale: Sleep Score [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 Health-related Quality of Life (HRQoL) Subscale: Social Score [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 Health-related Quality of Life (HRQoL) Subscale: Total Score [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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.
- Number of OAB-q Responders Based on Health-related Quality of Life: Total Score [ Time Frame: Baseline and up to 52 weeks of FDC 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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]
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 [ Time Frame: Baseline and up to 52 weeks of FDC treatment ]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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Completion of 12 weeks double-blind treatment in Study 905-CL-055
Exclusion Criteria:
- Any significant PVR volume (>150 mL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021332
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| Study Chair: | Use Central Contact | Astellas Pharma Global Development |
| Responsible Party: | Astellas Pharma Europe B.V. |
| ClinicalTrials.gov Identifier: | NCT01021332 |
| Other Study ID Numbers: |
905-CL-057 2008-001212-20 ( EudraCT Number: EudraCT ) |
| First Posted: | November 26, 2009 Key Record Dates |
| Results First Posted: | January 22, 2016 |
| Last Update Posted: | December 18, 2017 |
| Last Verified: | November 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com. |
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Vesomni Solifenacin succinate EC905 Tamsulosin hydrochloride OCAS |
Treatment Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia |
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Prostatic Hyperplasia Hyperplasia Lower Urinary Tract Symptoms Pathologic Processes Prostatic Diseases Urological Manifestations Tamsulosin Solifenacin Succinate Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |