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

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

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 Overview

• Status: Unknown
• Conditions: Benign Prostate Hyperplasia
• Intervention / Treatment: Drug: Tamsulosin; Drug: Solifenacin; Drug: Solifenacin placebo

• Study Type: Interventional
• Enrollment (Anticipated): 588
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Kyu Sung Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin; Solifenacin Succinate
• Other Study ID Numbers: ID-TASO-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No