UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018743 |
|---|---|
| Receipt number | R000021187 |
| Scientific Title | Evaluation of silodosin versus tadalafil in patients with urination disorders associated with benign prostatic hyperplasia |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2017/09/07 10:36:21 |
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Basic information
Public title
Evaluation of silodosin versus tadalafil in patients with urination disorders associated with benign prostatic hyperplasia
Acronym
Evaluation of silodosin versus tadalafil in patients with urination disorders associated with benign prostatic hyperplasia
Scientific Title
Evaluation of silodosin versus tadalafil in patients with urination disorders associated with benign prostatic hyperplasia
Scientific Title:Acronym
Evaluation of silodosin versus tadalafil 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
< Treatment period I >
This research is intended to evaluate the efficacy and safety of oral administration of silodosin 8 mg/day or tadalafil 5 mg/day for 8 weeks in patients with urination disorders associated with benign prostatic hyperplasia using a parallel-group design.
< Treatment period II >
Subjects in the tadalafil group in treatment period I will be divided into 2 groups; a group switched to silodosin 8 mg/day and a group continuing tadalafil 5 mg/day to evaluate the efficacy and safety of oral administration of each drug for 8 weeks using a parallel-group design.
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 (treatment period I, Weeks 1, 2, 3, 4: treatment period II, Weeks 9, 10, 11, 12)
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) Subgroup analyses of primary/secondary endpoints by subject's baseline characteristic (age, BMI, duration of illness, OAB/ED/renal disease/hepatic disease and other complications, treatment history, prostate volume, baseline data of each endpoint at the start of treatment [Week 0])
11) 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
3
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 8 weeks.
Interventions/Control_2
Tadalafil 5 mg will be orally administered once daily for 8 weeks.
Subsequently, Tadalafil will be switched to silodosin 4 mg, which will be orally administered twice daily after breakfast and dinner for 8 weeks.
Interventions/Control_3
Tadalafil 5 mg will be orally administered once daily for 8 weeks.
Subsequently, Tadalafil 5 mg will continue to be orally administered once daily for 8 weeks.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients diagnosed with benign prostatic hyperplasia by digital rectal examination or ultrasonography who provide written consent to participate in the research.
1) Patients meet the following conditions as confirmed through inspection and examination at the start of treatment (Week 0):
Total IPSS Score of 13 or higher
QOL score of 3 or higher
Prostate volume of 20 mL or higher
Residual urine volume of 100 mL or less
2) Patients are 60 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 or tadalafil.
2) Patients have prostate cancer.
3) Patients have lower urinary tract symptoms possibly due to urinary tract infection or neurogenic bladder.
4) Patients have used silodosin or tadalafil within 12 weeks prior to Week 0.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Yoshida |
Organization
National Center for Geriatrics and Gerontology
Division name
Division of Urology, Department of Surgery and Intensive Care
Zip code
Address
7-430 Morioka-cho, Obu, Aichi, Japan
TEL
0562-46-2311
myoshida@ncgg.go.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
silodosin@mebix.co.jp
Sponsor or person
Institute
Kissei Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
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
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 | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/luts.12177/epdf
Number of participants that the trial has enrolled
Results
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
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 21 | 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 | 08 | Month | 20 | Day |
Last modified on
| 2017 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021187
