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

March 17, 2016 updated by: Astellas Pharma Taiwan, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamsulosin alone
Drug: Tamsulosin
Oral
Other Names:
  • Harnalidge® D
Experimental: Tamsulosin + solifenacin
Drug: Solifenacin
Oral
Other Names:
  • Vesicare®
Drug: Tamsulosin
Oral
Other Names:
  • Harnalidge® D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline and end of treatment (up to 12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)
Baseline and end of treatment (up to 12 weeks)
Safety as assessed by adverse events
Time Frame: Up to 12 weeks
Up to 12 weeks
Safety as assessed by postvoid residual volume (PVR)
Time Frame: Up to 12 weeks
Measured by bladder scan
Up to 12 weeks
Safety as assessed by vital signs
Time Frame: Up to 12 weeks
Up to 12 weeks
Safety as assessed by laboratory parameters
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Taiwan, Inc.

Investigators

  • Study Director: Therapeutic Area Lead of Medical Affairs (Asia-Oceania), Astellas Pharma Taiwan, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAURO-0605-TW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overactive Bladder

Clinical Trials on Solifenacin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe