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

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ClinicalTrials.gov Identifier: NCT02827578
Recruitment Status : Unknown
Verified April 2016 by IlDong Pharmaceutical Co Ltd.
Recruitment status was:  Recruiting
First Posted : July 11, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

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 Type : Interventional  (Clinical Trial)
Estimated 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 : January 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. The change of TUFS((Total Urgency and Frequency Score)/24h [ Time Frame: From baseline at week 12 ]
  2. The change of total IPSS(International prostate symptom score) [ Time Frame: From baseline at week 12 ]

Secondary Outcome Measures :
  1. The change of urgency/24h [ Time Frame: From baseline at week 4, 8 and 12 ]
  2. The change of voiding frequency/24h [ Time Frame: From baseline at week 4, 8 and 12 ]
  3. The change of nocturnal frequency/24h [ Time Frame: From baseline at week 4, 8 and 12 ]
  4. The change of urge urinary incontinence frequency/24h [ Time Frame: From baseline at week 4, 8 and 12 ]
  5. The change of IPSS(International prostate symptom score)-sub score [ Time Frame: From baseline at week 4, 8 and 12 ]
  6. The change of PPBC(Patient perception of bladder condition) [ Time Frame: From baseline at week 4 and 12 ]
  7. The change of IPSS(International prostate symptom score) QoL(Quality of Life) [ Time Frame: From baseline at week 4, 8 and 12 ]
  8. PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change) [ Time Frame: From baseline at week 12 ]
  9. The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4 [ Time Frame: From baseline at week 12 ]


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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827578


Contacts
Contact: moah Son sonmoah@ildong.com

Locations
Korea, Republic of
Samsung medical center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Kyu Sung Lee         
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd

Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02827578     History of Changes
Other Study ID Numbers: ID-TASO-301
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Tamsulosin
Solifenacin Succinate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents