UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017896 |
|---|---|
| Receipt number | R000020732 |
| Scientific Title | The study for evaluating the additional effect of tadalafil in patients with the residual lower urinary tract storage symptoms even after treatment with alpha-1-adrenoreceptor antagonists |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/06/13 12:05:04 |
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Basic information
Public title
The study for evaluating the additional effect of tadalafil in patients with the residual lower urinary tract storage symptoms even after treatment with alpha-1-adrenoreceptor antagonists
Acronym
The study for evaluating the additional effect of tadalafil in patients with the residual storage symptoms even after treatment with alpha-1-adrenoreceptor antagonists
Scientific Title
The study for evaluating the additional effect of tadalafil in patients with the residual lower urinary tract storage symptoms even after treatment with alpha-1-adrenoreceptor antagonists
Scientific Title:Acronym
The study for evaluating the additional effect of tadalafil in patients with the residual storage symptoms even after treatment with alpha-1-adrenoreceptor antagonists
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia (BPH)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of tadalafil with anti cholonergic agents, which is the first line therapy in guideline, as add-on therapy to alpha-1-adrenoreceptor antagonists in patients with inadequately controlled lower urinary tract storage symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IPSS (International prostate symptom score) storage subscore
Key secondary outcomes
IPSS-QOL score, OABSS, N-QOL (Nocturia Quality of Life questionnaire) score, adverse events, residual urine volume, Qmax, Qave, PGI-I (Patient Global Impression of Improvement), CGI-I (Clinician Global Impression of Improvement)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Alpha-1-adrenoreceptor antagonists and tadalafil 5mg combined therapy (12 weeks)
Interventions/Control_2
Alpha-1-adrenoreceptor antagonists and anti cholinergic agents (Solifenacin succinate or Propiverine hydrochloride) combined therapy (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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
BPH (prostate volume more than 20 cc) with residual storage symptoms even after treatment with alpha-1-adrenoreceptor antagonists (patients meet the following 1-4 criteria)
1. Total IPSS score: 8 points or more
2. IPSS-QOL score: 2 points or more
3. OABSS: 3 points or more
4. Nighttime voiding frequency: 2 times or more
Key exclusion criteria
1. Patients under 50 years old
2. Patients with a history of known serious hypersensitivity reaction to tadalafil, solifenacin succinate or propiverine hydrochloride
3. Patients using nitrates or nitric oxide donors in any form (e.g. nitroglycerin, amyl nitrite or isosorbide dinitrate)
4. Patients using sGC (soluble guanylate cyclase) stimulator (riociguat)
5. Patients with unstable angina
6. Patients with heart failure (NYHA (New York Heart Association) Class 3 or greater)
7. Patients with inadequately controlled arrhythmia, hypotension (blood pressure lower than 90/50 mmHg) or inadequately controlled hypertension (blood pressure at rest higher than 170/100 mmHg)
8. Patients with a history of myocardial infarction within the last 3 months
9. Patients with a history of brain infarction/cerebral hemorrhage within the last 6 months
10. Patients with severe renal impairment
11. Patients with severe hepatic impairment (Child-Pugh Class C)
12. Patients with ischuria
13. Patients with closed angle glaucoma
14. Patients with obstruction in pyrolic part of stomach, duodenal ileus, enterocleisis, or paralytic ileus
15. Patients with gastroatonia/ intestinal atonia
16. Patients with myasthenia gravis
17. Patients with severe cardiac disease
18. Patients with prostate volume more than 50 cc
19. Patients with malignant tumor
20. Patients with a history of intrapelvic surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Urakami |
Organization
Toranomon Hospital
Division name
Urology
Zip code
Address
2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan
TEL
03-3588-1111
shinurakami@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Urakami |
Organization
Toranomon Hospital
Division name
Urology
Zip code
Address
2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan
TEL
03-3588-1111
Homepage URL
shinurakami@ybb.ne.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon 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 | 07 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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
Management information
Registered date
| 2015 | Year | 06 | Month | 13 | Day |
Last modified on
| 2015 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020732
