UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020031 |
|---|---|
| Receipt number | R000023133 |
| Scientific Title | Efficacy of the escalating dose of naftopidil for patients with benign prostatic enlargement complicated by overactive bladder |
| Date of disclosure of the study information | 2015/12/02 |
| Last modified on | 2015/12/02 00:07:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of the escalating dose of naftopidil for patients with benign prostatic enlargement complicated by overactive bladder
Acronym
Efficacy of naftopidil for BPH/OAB patients
Scientific Title
Efficacy of the escalating dose of naftopidil for patients with benign prostatic enlargement complicated by overactive bladder
Scientific Title:Acronym
Efficacy of naftopidil for BPH/OAB patients
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of the escalating dose of naftopidilfor patients with benign prostatic enlargement complicated by overactive bladder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the improvement of overactive bladder by escalating the dose of naftopidilfor patients with benign prostatic enlargement complicated by overactive bladder
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
the intake of naftopidil
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
The inclusion criteria were as follows: Total International Prostate Symptom Score (IPSS) > 8; IPSS-QOL score > 3; total OAB symptom scores (OABSS) > 3; urinary urgency episodes> 1 per week; prostate volume > 25 mL as determined based on transabdominal ultrasonography; maximum urinary flow rate (Qmax) < 15 mL/sec at voided volume of > 100 mL; and residual urine < 150 mL; age > 50 years.
Key exclusion criteria
Patients were excluded if they received oral treatment with alpha1-blockers, anticholinergic agents, 5-alpha reductase inhibitor (5-ARI), antidepressants, anti-anxiety agents, or sex hormonal agents; had neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection; and had severe cardiac disease, renal dysfunction (serum creatinine level > 2 mg/dL), and hepatic dysfunction (aspartate and alanine aminotransferase concentrations more than twice the normal values).
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsukawa Yoshihisa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
+81-52-744-2985
yoshi44@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsukawa Yoshihisa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
+81-52-744-2985
Homepage URL
yoshi44@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Urology
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 02 | 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
| 2010 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 02 | Day |
Last modified on
| 2015 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023133
