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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017896
Receipt No. 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

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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
Email 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
Email shinurakami@ybb.ne.jp

Sponsor
Institute Toranomon Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020732

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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