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

NCT02827578 | Unknown Phase 3

• 1 other identifier: ID-TASO-301
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 1

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

Conditions

Benign Prostate Hyperplasia

Outcome Measures

Primary Outcomes (2)

• The change of TUFS((Total Urgency and Frequency Score)/24h

  From baseline at week 12

• The change of total IPSS(International prostate symptom score)

  From baseline at week 12

Secondary Outcomes (9)

• 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

Study Arms (2)

Tamsulosin + Solifenacin

EXPERIMENTAL

Tamsulosin and Solifenacin

Drug: Tamsulosin; Drug: Solifenacin

Tamsulosin + Solifenacin Placebo

ACTIVE COMPARATOR

Tamsulosin and Solifenacin placebo

Drug: Tamsulosin; Drug: Solifenacin placebo

Interventions

Tamsulosin DRUG

Tamsulosin

Tamsulosin + Solifenacin; Tamsulosin + Solifenacin Placebo

Solifenacin DRUG

Solifenacin

Tamsulosin + Solifenacin

Solifenacin placebo DRUG

Solifenacin placebo

Tamsulosin + Solifenacin Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Samsung medical center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

moah Son

CONTACT

sonmoah@ildong.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 11, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 13, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)