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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
Astellas Pharma Taiwan, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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

First Posted
March 17, 2016
Last Updated
March 17, 2016
Sponsor
Astellas Pharma Taiwan, Inc.
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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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