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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

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ClinicalTrials.gov Identifier: NCT02715024
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Taiwan, Inc. )

Tracking Information
First Submitted Date  ICMJE March 17, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date March 22, 2016
Study Start Date  ICMJE September 2007
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Safety as assessed by adverse events [ Time Frame: Up to 12 weeks ]
  • Safety as assessed by postvoid residual volume (PVR) [ Time Frame: Up to 12 weeks ]
    Measured by bladder scan
  • Safety as assessed by vital signs [ Time Frame: Up to 12 weeks ]
  • Safety as assessed by laboratory parameters [ Time Frame: Up to 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lower Urinary Tract Symptoms
  • Overactive Bladder
  • Benign Prostatic Hyperplasia (BPH)
Intervention  ICMJE
  • Drug: Tamsulosin
    Oral
    Other Name: Harnalidge® D
  • Drug: Solifenacin
    Oral
    Other Name: Vesicare®
Study Arms  ICMJE
  • Experimental: Tamsulosin alone
    Intervention: Drug: Tamsulosin
  • Experimental: Tamsulosin + solifenacin
    Interventions:
    • Drug: Tamsulosin
    • Drug: Solifenacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2016)
52
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02715024
Other Study ID Numbers  ICMJE HAURO-0605-TW
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Astellas Pharma Inc ( Astellas Pharma Taiwan, Inc. )
Study Sponsor  ICMJE Astellas Pharma Taiwan, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Therapeutic Area Lead of Medical Affairs (Asia-Oceania) Astellas Pharma Taiwan, Inc.
PRS Account Astellas Pharma Inc
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP