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

NCT02972268 | Completed Phase 3

• 1 other identifier: JLP-1207-P3
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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

Conditions

Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• change of TUFS

  12 weeks from baseline

• change of total IPSS

  12 weeks from baseline

Study Arms (2)

Group I

EXPERIMENTAL

Tamsulosin 0.2mg + Solifenacin 5mg

Drug: Tamsulosin 0.2mg + Solifenacin 5mg

Group II

PLACEBO COMPARATOR

Tamsulosin 0.2mg + Placebo(Solifenacin)

Drug: Tamsulosin 0.2mg + Placebo(Solifenacin)

Interventions

Tamsulosin 0.2mg + Solifenacin 5mg DRUG

Tamsulosin 0.2mg + Solifenacin 5mg for 12wks

Group I

Tamsulosin 0.2mg + Placebo(Solifenacin) DRUG

Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks

Group II

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Interventions

Tamsulosin; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital 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

• Myung Soo Choo, MD., Ph.D

  Asan Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 23, 2016
• Study Start: February 1, 2016
• Primary Completion: November 2, 2017
• Study Completion: August 14, 2018
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)