UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019323 |
|---|---|
| Receipt number | R000022342 |
| Scientific Title | Efficacy and Safety of the Tadarafil Monotherapy or Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2016/10/15 18:04:56 |
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Basic information
Public title
Efficacy and Safety of the Tadarafil Monotherapy or Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study
Acronym
TMCTD study
Scientific Title
Efficacy and Safety of the Tadarafil Monotherapy or Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study
Scientific Title:Acronym
TMCTD study
Region
| Japan |
Condition
Condition
Benign Prostatic Hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyse the efficacy and safety of the coadministration of Tadarafil and Dutasteride for Benign Prostatic Hyperplasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Total international prostate symptom score on 12 weeks after administration
Key secondary outcomes
Total IPSS on 24 weeks after administration
IPSS sub-score, OABSS, IIEF5, AMS Score, SF-8, Uroflowmetry, Post-voided residual volume, prostate volume, blood pressure, adverse effect on 4, 12, and 24 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Tadarafil alone
5mg once a day oral administration
Interventions/Control_2
Tadarafil + Dutasteride
Tadarafil 5mg once a day oral administration
Dutasteride 0.5mg once a day oral administration
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
Male aged 50 or higher with prostate volume of 30 ml or higher and IPSS of 8 or higher
Key exclusion criteria
1) Prostate cancer
2) Neurogenic bladder
3) no administration of drugs for overactive bladder and BPH exclude a1-blocker
4) no administration of Dutasteride, Finasteride, anti-androgen, and testosterone within 6 months
5) no administration of PDE5 inhibitors
6) contraindication of Tadarafil
7) contraindication of Dutasteride
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Nishiyama |
Organization
Uonuma Institute of Community Medicine
Niigata University Medical and Dental Hospital
Division name
Department of Urology
Zip code
Address
Urasa 4132, Minamiuonumashi, Niigata 949-7302, Japan.
TEL
025-777-3200
nisiyama@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Nishiyama |
Organization
Uonuma Institute of Community Medicine Niigata University Medical and Dental Hospital
Division name
Department of Urology
Zip code
Address
Urasa 4132, Minamiuonumashi, Niigata 949-7302, Japan.
TEL
025-777-3200
Homepage URL
nisiyama@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Urology
Uonuma Institute of Community Medicine
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology
Uonuma Institute of Community Medicine
Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization
Self funding
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 | 11 | Month | 01 | 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
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 | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Because domestic supply of dutasteride had stopped and there is instability of the supply of dutasteride.
Management information
Registered date
| 2015 | Year | 10 | Month | 13 | Day |
Last modified on
| 2016 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022342
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
