Clinical trial NCT02827578: Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Benign Prostate Hyperplasia
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 588
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The change of TUFS((Total Urgency and Frequency Score)/24h
timeFrame: From baseline at week 12
measure: The change of total IPSS(International prostate symptom score)
timeFrame: From baseline at week 12
Secondary outcomes:
measure: The change of urgency/24h
timeFrame: From baseline at week 4, 8 and 12
measure: The change of voiding frequency/24h
timeFrame: From baseline at week 4, 8 and 12
measure: The change of nocturnal frequency/24h
timeFrame: From baseline at week 4, 8 and 12
measure: The change of urge urinary incontinence frequency/24h
timeFrame: From baseline at week 4, 8 and 12
measure: The change of IPSS(International prostate symptom score)-sub score
timeFrame: From baseline at week 4, 8 and 12
measure: The change of PPBC(Patient perception of bladder condition)
timeFrame: From baseline at week 4 and 12
measure: The change of IPSS(International prostate symptom score) QoL(Quality of Life)
timeFrame: From baseline at week 4, 8 and 12
measure: PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change)
timeFrame: From baseline at week 12
measure: The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4
timeFrame: From baseline at week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References: