Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms
Primary Purpose
Lower Urinary Tract Symptoms, Overactive Bladder, Benign Prostatic Hyperplasia (BPH)
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Tamsulosin
Solifenacin
Sponsored by
About this trial
This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring Tamsulosin, Solifenacin, Lower urinary tract symptoms, Overactive bladder
Eligibility Criteria
Inclusion Criteria:
- Clinical signs and symptoms of frequency and urgency related to benign prostatic hyperplasia for at least 3 months
- I-PSS(S) score of ≥ 12
- Maximum flow rate (Qmax) of 4 to15 mL/sec
- Mean urinary frequency of ≥ 8 micturitions per 24 hours and ≥ 1 episode of urgency per 24 hours as verified by the 3-day micturition diary
- Benign digital rectal examination (DRE) result
Exclusion Criteria:
- Clinically significant outflow obstruction
- Significant post void residue volume (PVR >100ml)
- Prostate specific antigen (PSA) ≥10 ng/mL
- Previous or planned prostate surgery, including transurethral resection of the prostate (TURP)
- Transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other invasive or minimally invasive procedures within 12 months
- Patient with a neurological cause for abnormal detrusor activity
- Patients with urinary tract infection, chronic inflammation, bladder stones, bladder neck, sclerosis, urethral stricture, prostatic cancer, severe vesical diverticulum
- Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
- Patients with any other complication which may cause voiding dysfunction
- Patients with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorder, orthostatic hypotension, or senile dementia
- Patients receiving any medication therapy for LUTS/BPH 2 weeks prior to the study
- Use of drugs to treat incontinence currently
- Hypersensitivity to tamsulosin and/or solifenacin or to any component of the formulation
- Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
- Patients had taken any investigational drug in the previous 3 months prior to this study
Sites / Locations
- Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tamsulosin alone
Tamsulosin + solifenacin
Arm Description
Outcomes
Primary Outcome Measures
Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment
Secondary Outcome Measures
Change in mean number of urgency episode per 24 hours from baseline to the end of treatment
Change in mean number of micturitions per 24 hours from baseline to the end of treatment
Change in Quality of life index (I-PSS-(L)) from baseline to the end of treatment
Change in maximum flow rate (Qmax) and voided volume determined by uroflowmetry from baseline to the end of treatment
Safety as assessed by adverse events
Safety as assessed by postvoid residual volume (PVR)
Measured by bladder scan
Safety as assessed by vital signs
Safety as assessed by laboratory parameters
Full Information
NCT ID
NCT02715024
First Posted
March 17, 2016
Last Updated
March 17, 2016
Sponsor
Astellas Pharma Taiwan, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02715024
Brief Title
Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms
Official Title
An Open-label, Randomized, Parallel Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Taiwan, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the clinical efficacy and safety of tamsulosin alone or in combination with solifenacin for the treatment in men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms in Taiwan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Overactive Bladder, Benign Prostatic Hyperplasia (BPH)
Keywords
Tamsulosin, Solifenacin, Lower urinary tract symptoms, Overactive bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin alone
Arm Type
Experimental
Arm Title
Tamsulosin + solifenacin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Harnalidge® D
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Solifenacin
Other Intervention Name(s)
Vesicare®
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment
Time Frame
Baseline and end of treatment (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Change in mean number of urgency episode per 24 hours from baseline to the end of treatment
Time Frame
Baseline and end of treatment (up to 12 weeks)
Title
Change in mean number of micturitions per 24 hours from baseline to the end of treatment
Time Frame
Baseline and end of treatment (up to 12 weeks)
Title
Change in Quality of life index (I-PSS-(L)) from baseline to the end of treatment
Time Frame
Baseline and end of treatment (up to 12 weeks)
Title
Change in maximum flow rate (Qmax) and voided volume determined by uroflowmetry from baseline to the end of treatment
Time Frame
Baseline and end of treatment (up to 12 weeks)
Title
Safety as assessed by adverse events
Time Frame
Up to 12 weeks
Title
Safety as assessed by postvoid residual volume (PVR)
Description
Measured by bladder scan
Time Frame
Up to 12 weeks
Title
Safety as assessed by vital signs
Time Frame
Up to 12 weeks
Title
Safety as assessed by laboratory parameters
Time Frame
Up to 12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical signs and symptoms of frequency and urgency related to benign prostatic hyperplasia for at least 3 months
I-PSS(S) score of ≥ 12
Maximum flow rate (Qmax) of 4 to15 mL/sec
Mean urinary frequency of ≥ 8 micturitions per 24 hours and ≥ 1 episode of urgency per 24 hours as verified by the 3-day micturition diary
Benign digital rectal examination (DRE) result
Exclusion Criteria:
Clinically significant outflow obstruction
Significant post void residue volume (PVR >100ml)
Prostate specific antigen (PSA) ≥10 ng/mL
Previous or planned prostate surgery, including transurethral resection of the prostate (TURP)
Transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other invasive or minimally invasive procedures within 12 months
Patient with a neurological cause for abnormal detrusor activity
Patients with urinary tract infection, chronic inflammation, bladder stones, bladder neck, sclerosis, urethral stricture, prostatic cancer, severe vesical diverticulum
Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
Patients with any other complication which may cause voiding dysfunction
Patients with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorder, orthostatic hypotension, or senile dementia
Patients receiving any medication therapy for LUTS/BPH 2 weeks prior to the study
Use of drugs to treat incontinence currently
Hypersensitivity to tamsulosin and/or solifenacin or to any component of the formulation
Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
Patients had taken any investigational drug in the previous 3 months prior to this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Therapeutic Area Lead of Medical Affairs (Asia-Oceania)
Organizational Affiliation
Astellas Pharma Taiwan, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms
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