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Recruitment status Terminated
Unique ID issued by UMIN UMIN000017995
Receipt No. R000020781
Scientific Title Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Date of disclosure of the study information 2015/06/22
Last modified on 2017/03/29

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Basic information
Public title Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Acronym Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Scientific Title Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Scientific Title:Acronym Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This research is intended to evaluate the efficacy and safety of switching tamsulosin hydrochloride to silodosin in patients with benign prostatic hyperplasia receiving combination therapy with tamsulosin hydrochloride and dutasteride for 12 weeks in comparison with continued treatment with tamsulosin hydrochloride and dutasteride.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in total IPSS score before and after treatment
Key secondary outcomes 1) Change in IPSS subscore before and after treatment
2) Percentage of subjects with an improvement of 25% or higher for total IPSS score
3) Change in QOL score before and after treatment
4) Change in OABSS score before and after treatment
5) Change in OABSS subscore before and after treatment
6) Changes in total IPSS score, QOL score, and OABSS score before and after treatment in the early stage of treatment (Weeks 1, 2, 3, 4)
7) Change in maximum urine flow rate before and after treatment
8) Change in mean urine flow rate before and after treatment
9) Change in residual urine volume before and after treatment
10) Acute urinary retention or surgery for benign prostatic hyperplasia
11) Subgroup analyses of primary/secondary endpoints by subject's baseline characteristic (age, BMI, duration of illness, OAB/renal disease/hepatic disease and other complications, treatment history, prostate volume, baseline data of each endpoint at the start of treatment [Week 0])
12) Adverse events and adverse drug reactions

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Silodosin 4 mg will be orally administered twice daily after breakfast and dinner for 12 weeks.
Interventions/Control_2 Tamsulosin hydrochloride 0.2 mg will be orally administered once daily after a meal for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Patients with benign prostatic hyperplasia receiving combination therapy with tamsulosin hydrochloride and dutasteride who provide written consent to participate in the research.
1) Patients have received tamsulosin hydrochloride for at least 12 weeks prior to the start of treatment (Week 0) and dutasteride for at least 24 weeks prior to Week 0 according to fixed doses and modes of administration.
2) Patients meet the following conditions as confirmed through inspection and examination at Week 0.
Total IPSS Score of 8 or higher
QOL score of 3 or higher
Residual urine volume of 150 mL or less
3) Patients are 50 years or older (at the time of consent).
Key exclusion criteria 1) Patients have any of the contraindications listed in the package inserts for silodosin, tamsulosin hydrochloride, or dutasteride.
2) Patients have prostate cancer.
3) Patients have lower urinary tract symptoms possibly due to urinary tract infection or neurogenic bladder.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyoshi Suzuki
Organization Toho University Sakura Medical Center
Division name Department of Urology
Zip code
Address 564-1 Shimoshizu, Sakura, Chiba, Japan
TEL 043-462-8811
Email hiroyoshi.suzuki@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsumi Watanabe
Organization Mebix, Inc.
Division name Research Promotion Division
Zip code
Address Akasaka Intercity, 1-11-44, Akasaka Minato-ku, Tokyo, Japan
TEL 03-4362-4504
Homepage URL
Email silodosin@mebix.co.jp

Sponsor
Institute Kissei Pharmaceutical Co.,Ltd.
Institute
Department

Funding Source
Organization Kissei Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This study was terminated because of  temporary shipping adjustment of dutasteride.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 21 Day
Last modified on
2017 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020781

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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