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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024578
Receipt No. R000028285
Scientific Title Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study
Date of disclosure of the study information 2016/12/20
Last modified on 2018/01/05

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Basic information
Public title Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study
Acronym The RESTORE study
Scientific Title Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study
Scientific Title:Acronym The RESTORE study
Region
Japan

Condition
Condition Benign prostate hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Variations of overacrive bladder symptom score (OABSS) at 8-week after the administration of each drug
Key secondary outcomes Variations of the items below at 4-week and 8-week after the administraion of each drug
- International prostate symptom score (IPSS): Total score, Storage subscore, and Voiding subscore
- International Index of Erectile Function (IIEF)
- Maximum urinary flow rate
- Post-void residual urine
- Mean voided volume
- Blood pressure on visits

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We will administer tadalafil 5mg/day for 8 weeks first and silodosin 8mg/day for 8 weeks second.
Interventions/Control_2 We will administer silodosin 8mg/day for 8 weeks first and tadalafil 5mg/day for 8 weeks second.
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 - Prostate volume is 20 mL and over.
- OABSS is 6 and over.
Key exclusion criteria - Prostate cancer
- Neurogenic bladder
- Under treatment with alpha1 blockers and/or OAB drugs
- Contraindication of tadalafil
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazumasa Torimoto
Organization Nara Medical University Hospital
Division name Urology
Zip code
Address 840 Shijo-cho, Kashihara, Nara, JAPAN
TEL +81-744-22-3051
Email torimoto@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumasa Torimoto
Organization Nara Medical University Hospital
Division name Urology
Zip code
Address 840 Shijo-cho, Kashihara, Nara, JAPAN
TEL +81-744-22-3051
Homepage URL
Email torimoto@naramed-u.ac.jp

Sponsor
Institute Department of Urology, Nara Medical University
Institute
Department

Funding Source
Organization Department of Urology, Nara Medical University
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 奈良県立医科大学附属病院(奈良県)、平尾病院(奈良県)、高井病院(奈良県)、大阪暁明館病院(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 20 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 20 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
2016 Year 10 Month 26 Day
Last modified on
2018 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028285

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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