Back to resultsClinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH
Primary Purpose
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tamsulosin 0.2mg + Solifenacin 5mg
Tamsulosin 0.2mg + Placebo(Solifenacin)
Sponsored by
About this trial
This is an interventional treatment trial for Lower Urinary Tract Symptoms
Eligibility Criteria
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.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group I
Group II
Arm Description
Tamsulosin 0.2mg + Solifenacin 5mg
Tamsulosin 0.2mg + Placebo(Solifenacin)
Outcomes
Primary Outcome Measures
change of TUFS
change of total IPSS
Secondary Outcome Measures
Full Information
NCT ID
NCT02972268
First Posted
November 21, 2016
Last Updated
August 27, 2019
Sponsor
Jeil Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02972268
Brief Title
Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
November 2, 2017 (Actual)
Study Completion Date
August 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
780 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
Tamsulosin 0.2mg + Solifenacin 5mg
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
Tamsulosin 0.2mg + Placebo(Solifenacin)
Intervention Type
Drug
Intervention Name(s)
Tamsulosin 0.2mg + Solifenacin 5mg
Intervention Description
Tamsulosin 0.2mg + Solifenacin 5mg for 12wks
Intervention Type
Drug
Intervention Name(s)
Tamsulosin 0.2mg + Placebo(Solifenacin)
Intervention Description
Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks
Primary Outcome Measure Information:
Title
change of TUFS
Time Frame
12 weeks from baseline
Title
change of total IPSS
Time Frame
12 weeks from baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung Soo Choo, MD., Ph.D
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH
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