Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia

Phase 3

• Conditions: Benign Prostate Hyperplasia
• Interventions: Drug: Tamsulosin; Drug: Solifenacin; Drug: Solifenacin placebo

• Registration Number: NCT02827578
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Brief Summary

Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-04
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-13
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 588

Inclusion Criteria

1. Healthy male aged 45 years old or older
2. Subjects with benign prostatic hyperplasia diagnosed by digital rectal examination
3. Subjects with lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form

Exclusion Criteria

1. Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 5 years
2. Subjects who have acute urinary retention within 4 weeks before screening
3. Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 6 months before screening
4. Subjects who have hypersensitivity to investigational product or sulfa medications
5. Subjects who were suspected or confirmed calculus of lower urinary tract, calculus of bladder (except for complete recovery,)
6. Subjects who have myasthenia gravis, narrow angle glaucoma or autonomic neuropathy
7. Subjects who have cataract or glaucoma scheduled to be operated in the study duration.
8. Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
9. Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosin + Solifenacin	Tamsulosin	Tamsulosin and Solifenacin
Tamsulosin + Solifenacin	Solifenacin	Tamsulosin and Solifenacin
Tamsulosin + Solifenacin Placebo	Solifenacin placebo	Tamsulosin and Solifenacin placebo
Tamsulosin + Solifenacin Placebo	Tamsulosin	Tamsulosin and Solifenacin placebo

Primary Outcome Measures

Name	Time	Method
The change of total IPSS(International prostate symptom score)	From baseline at week 12
The change of TUFS((Total Urgency and Frequency Score)/24h	From baseline at week 12

Secondary Outcome Measures

Name	Time	Method
The change of IPSS(International prostate symptom score) QoL(Quality of Life)	From baseline at week 4, 8 and 12
The change of voiding frequency/24h	From baseline at week 4, 8 and 12
The change of nocturnal frequency/24h	From baseline at week 4, 8 and 12
The change of IPSS(International prostate symptom score)-sub score	From baseline at week 4, 8 and 12
The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4	From baseline at week 12
The change of urgency/24h	From baseline at week 4, 8 and 12
The change of urge urinary incontinence frequency/24h	From baseline at week 4, 8 and 12
The change of PPBC(Patient perception of bladder condition)	From baseline at week 4 and 12
PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change)	From baseline at week 12

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of