UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011980 |
|---|---|
| Receipt number | R000013993 |
| Scientific Title | Effect of Dutasteride and Imidafenacin in BPH/OAB patients not respond to eight weeks'continuous treatment of Tamsulosin. |
| Date of disclosure of the study information | 2013/10/11 |
| Last modified on | 2016/04/07 09:28:47 |
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Basic information
Public title
Effect of Dutasteride and Imidafenacin in BPH/OAB patients
not respond to eight weeks'continuous treatment of Tamsulosin.
Acronym
Effect of Dutasteride and Imidafenacin in BPH/OAB patients
not respond to eight weeks'continuous treatment of Tamsulosin. (DIrecT Study)
Scientific Title
Effect of Dutasteride and Imidafenacin in BPH/OAB patients
not respond to eight weeks'continuous treatment of Tamsulosin.
Scientific Title:Acronym
Effect of Dutasteride and Imidafenacin in BPH/OAB patients
not respond to eight weeks'continuous treatment of Tamsulosin. (DIrecT Study)
Region
| Japan |
Condition
Condition
benign prostatic hypertrophy
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the usefulness of the add-on therapy with Imidafenacin and Dutasteride in OAB/BPH patients taking Tamsulosin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of total OABSS score
Key secondary outcomes
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
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Imidafenacin 0.1mg will be orally administered twice a day,once after breakfast and dinner for 52 weeks. Dutasteride 0.5mg will be orally administered once a day,once after breakfast for 52 weeks.
Interventions/Control_2
Dutasteride 0.5mg will be orally administered once a day,once after breakfast for 52 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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
1) Patients who have the following criteria in overactive bladder symptom score (OABSS) even after administering Tamsulosin for more than 8 weeks
Urgency score >= 2
Total score >=3
2) Aged >=50 years and <90 years
3) Prostate volume >=30mL
4) Patients who are able to give informed consent.
5) Patients from whom we have received written consent.
Key exclusion criteria
1) Patients with a history of hypersensitivity to Tamsulosin, Dutasteride or Imidafenacin
2) Patients who have administered prohibited substances in the 2 weeks prior to randomization (6 months for 5ARIsand/or anti-androgenics)
3) Patients who have done prohibited therapy in the 8 weeks prior to randomization
4) History or current condition of urinary retention or severe difficulty of urination
5) Patients with cancer in the part of lower urinary tract such as prostate or bladder, neurogenic bladder, urethra stricture, chronic prostatitis, symptomatic urinary tract infection, urinary tract stones and interstitial cystitis
6) Patients with serious cardiac disorder, serious liver dysfunction and serious kidney dysfunction
7) Patients with orthostatic hypotension
8) Patients with pyloristenosis, constriction of dodecadactylon, construction of enteron and adynamic ileus
9) Patients with deterioration of enterokinesis
10) Patients with narrow-angle glaucoma
11) Patients with myasthenia gravis
12) Qmax <5 mL/s
13) Residual urine volume >100 mL
14) Serum PSA >10 ng/mL
15) Patients with Polyuria
16) Any other patients who are regarded as unsuitable for this study by the investigator
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Yamanishi |
Organization
Dokkyo Medical University
Division name
Department of Urology and Neurology, Continence Center
Zip code
Address
Kitakobayashi 880, Mibu, Shimotsuga, Tochigi, Japan
TEL
0282-86-1111
yamanish@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Yamanishi |
Organization
Dokkyo Medical University
Division name
Department of Urology and Neurology, Continence Center
Zip code
Address
Kitakobayashi 880, Mibu, Shimotsuga, Tochigi, Japan
TEL
0282-86-1111
Homepage URL
yamanish@dokkyomed.ac.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
Kyorin Pharmaceutical Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2013 | Year | 10 | Month | 11 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 12 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 07 | Day |
Last modified on
| 2016 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013993
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