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

• Sponsor: IlDong Pharmaceutical Co Ltd (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02827578
• Collaborator: (none)
• Enrollment: 588
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 25.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Benign Prostate Hyperplasia	Drug: Tamsulosin; Drug: Solifenacin; Drug: Solifenacin placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 588 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Aug 1, 2017
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tamsulosin + Solifenacin Tamsulosin and Solifenacin	Drug: Tamsulosin; Tamsulosin; Drug: Solifenacin; Solifenacin
Active Comparator: Tamsulosin + Solifenacin Placebo Tamsulosin and Solifenacin placebo	Drug: Tamsulosin; Tamsulosin; Drug: Solifenacin placebo; Solifenacin placebo

Outcome Measures

Primary Outcome Measures

1. The change of TUFS((Total Urgency and Frequency Score)/24h [From baseline at week 12]

2. The change of total IPSS(International prostate symptom score) [From baseline at week 12]

Secondary Outcome Measures

1. The change of urgency/24h [From baseline at week 4, 8 and 12]

2. The change of voiding frequency/24h [From baseline at week 4, 8 and 12]

3. The change of nocturnal frequency/24h [From baseline at week 4, 8 and 12]

4. The change of urge urinary incontinence frequency/24h [From baseline at week 4, 8 and 12]

5. The change of IPSS(International prostate symptom score)-sub score [From baseline at week 4, 8 and 12]

6. The change of PPBC(Patient perception of bladder condition) [From baseline at week 4 and 12]

7. The change of IPSS(International prostate symptom score) QoL(Quality of Life) [From baseline at week 4, 8 and 12]

8. PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change) [From baseline at week 12]

9. The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4 [From baseline at week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung medical center	Seoul		Korea, Republic of

Sponsors and Collaborators

• IlDong Pharmaceutical Co Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IlDong Pharmaceutical Co Ltd
• ClinicalTrials.gov Identifier: NCT02827578
• Other Study ID Numbers: ID-TASO-301
• First Posted: Jul 11, 2016
• Last Update Posted: Jul 13, 2016
• Last Verified: Apr 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Tamsulosin; Solifenacin Succinate

Study Results

No Results Posted as of Jul 13, 2016