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

Benign Prostate Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02827578
• Other study ID #: ID-TASO-301
• Status: Recruiting
• Phase: Phase 3
• First received: July 6, 2016
• Last updated: July 11, 2016
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: IlDong Pharmaceutical Co Ltd
• Contact: moah Son
• Email: sonmoah[@]ildong.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 588
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Tamsulosin
Tamsulosin
• Solifenacin
Solifenacin
• Solifenacin placebo
Solifenacin placebo

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of TUFS((Total Urgency and Frequency Score)/24h		From baseline at week 12	No
Primary	The change of total IPSS(International prostate symptom score)		From baseline at week 12	No
Secondary	The change of urgency/24h		From baseline at week 4, 8 and 12	No
Secondary	The change of voiding frequency/24h		From baseline at week 4, 8 and 12	No
Secondary	The change of nocturnal frequency/24h		From baseline at week 4, 8 and 12	No
Secondary	The change of urge urinary incontinence frequency/24h		From baseline at week 4, 8 and 12	No
Secondary	The change of IPSS(International prostate symptom score)-sub score		From baseline at week 4, 8 and 12	No
Secondary	The change of PPBC(Patient perception of bladder condition)		From baseline at week 4 and 12	No
Secondary	The change of IPSS(International prostate symptom score) QoL(Quality of Life)		From baseline at week 4, 8 and 12	No
Secondary	PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change)		From baseline at week 12	No
Secondary	The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4		From baseline at week 12	No