Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH

August 27, 2019 updated by: Jeil Pharmaceutical Co., Ltd.

Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

780

Phase

  • Phase 3

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

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Over 45 years
  • Benign Prostate Hyperplasia diagnosed by 20 mL < TRUS
  • Lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form

Exclusion Criteria:

  • Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years
  • Subjects who have acute urinary retention within 12 weeks before screening
  • Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening
  • Subjects who have hypersensitivity to investigational product
  • Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum
  • Subjects who have myasthenia gravis, narrow angle glaucoma
  • Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • SBP > 180 mmHg or DBP > 100 mmHg
  • HbA1c > 9.0 %
  • Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
Tamsulosin 0.2mg + Solifenacin 5mg
Drug: Tamsulosin 0.2mg + Solifenacin 5mg
Tamsulosin 0.2mg + Solifenacin 5mg for 12wks
Placebo Comparator: Group II
Tamsulosin 0.2mg + Placebo(Solifenacin)
Drug: Tamsulosin 0.2mg + Placebo(Solifenacin)
Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of TUFS
Time Frame: 12 weeks from baseline
12 weeks from baseline
change of total IPSS
Time Frame: 12 weeks from baseline
12 weeks from baseline

Collaborators and Investigators

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

Sponsor

Jeil Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: Myung Soo Choo, MD., Ph.D, Asan Medical Center

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 (Actual)

February 1, 2016

Primary Completion (Actual)

November 2, 2017

Study Completion (Actual)

August 14, 2018

Study Registration Dates

First Submitted

November 21, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLP-1207-P3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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