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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. )

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.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Overactive Bladder Benign Prostatic Hyperplasia (BPH) Drug: Tamsulosin Drug: Solifenacin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tamsulosin alone Drug: Tamsulosin
Oral
Other Name: Harnalidge® D

Experimental: Tamsulosin + solifenacin Drug: Tamsulosin
Oral
Other Name: Harnalidge® D

Drug: Solifenacin
Oral
Other Name: Vesicare®




Primary Outcome Measures :
  1. 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 Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. Safety as assessed by adverse events [ Time Frame: Up to 12 weeks ]
  6. Safety as assessed by postvoid residual volume (PVR) [ Time Frame: Up to 12 weeks ]
    Measured by bladder scan

  7. Safety as assessed by vital signs [ Time Frame: Up to 12 weeks ]
  8. Safety as assessed by laboratory parameters [ Time Frame: Up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT02715024


Locations
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Taiwan
Site
Taipei, Taiwan
Sponsors and Collaborators
Astellas Pharma Taiwan, Inc.
Investigators
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Study Director: Therapeutic Area Lead of Medical Affairs (Asia-Oceania) Astellas Pharma Taiwan, Inc.
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Responsible Party: Astellas Pharma Taiwan, Inc.
ClinicalTrials.gov Identifier: NCT02715024    
Other Study ID Numbers: HAURO-0605-TW
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Taiwan, Inc. ):
Tamsulosin
Solifenacin
Lower urinary tract symptoms
Overactive bladder
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Prostatic Diseases
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