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

NCT02715024 | Completed Phase 4

• 1 other identifier: HAURO-0605-TW
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms; Overactive Bladder; Benign Prostatic Hyperplasia (BPH)

Keywords

Tamsulosin; Solifenacin; Lower urinary tract symptoms; Overactive bladder

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment

  Baseline and end of treatment (up to 12 weeks)

Secondary Outcomes (8)

• Change in mean number of urgency episode per 24 hours from baseline to the end of treatment

  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

  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

  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

  Baseline and end of treatment (up to 12 weeks)

• Safety as assessed by adverse events

  Up to 12 weeks

Study Arms (2)

Tamsulosin alone

EXPERIMENTAL

Drug: Tamsulosin

Tamsulosin + solifenacin

EXPERIMENTAL

Drug: Tamsulosin; Drug: Solifenacin

Interventions

Tamsulosin DRUG

Oral

Also known as: Harnalidge® D

Tamsulosin + solifenacin; Tamsulosin alone

Solifenacin DRUG

Oral

Also known as: Vesicare®

Tamsulosin + solifenacin

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Taiwan, Inc.: lead

Study Sites (1)

Site

Taipei, Taiwan

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder, Overactive; Prostatic Hyperplasia

Interventions

Tamsulosin; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Therapeutic Area Lead of Medical Affairs (Asia-Oceania)

  Astellas Pharma Taiwan, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: September 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

TW (1)