UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016050 |
|---|---|
| Receipt number | R000018654 |
| Scientific Title | A clinical for evaluating the effect of L-citrulline and PDE5 inhibitor on erectile dysfunction and dysuria |
| Date of disclosure of the study information | 2014/12/25 |
| Last modified on | 2018/12/27 10:03:30 |
* 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
A clinical for evaluating the effect of L-citrulline and PDE5 inhibitor on erectile dysfunction and dysuria
Acronym
A clinical for evaluating the effect of L-citrulline on erectile dysfunction and dysuria
Scientific Title
A clinical for evaluating the effect of L-citrulline and PDE5 inhibitor on erectile dysfunction and dysuria
Scientific Title:Acronym
A clinical for evaluating the effect of L-citrulline on erectile dysfunction and dysuria
Region
| Japan |
Condition
Condition
Benign Prostatic Hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of L-citrulline and PDE5 inhibitor intake for 8weeks on the function of corpus cavernosum and dysuria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Erectile function (IIEF,EHS)
Key secondary outcomes
IPSS,OABSS,frequency volume chart,UFM,residual urine,SEP2, SEP3, GAQ,VAS,blood biochemistry
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of L-citruline for 8weeks
Interventions/Control_2
Intake of placebo for 8weeks
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
| 45 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Subject aged from 45 to 75 years
2.Subject taking PDE5 inhibitor for 4weeks to treat Benign Prostatic Hyperplasia.
3.Subject classified IIEF score 8 to 25
4.Subject having sexual intercourse at least once a 8 week.
Key exclusion criteria
1.Subject receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders
2.Subject having a neurological disease
3.Subject having penile organic dysfunction
4.Subject having endocrine disease
5.Subject injecting insulin
6.Subject receiving hormone replacement therapy
7.Subject diagnosed psychogenic ED
8.Subject having the habit of taking a L-citrulline
9.Subject judged to be ineligible by the investigator for other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Kimura |
Organization
Graduate School of Medical Sciences, Nagoya City University
Division name
Department of Clinical Pharmacy
Zip code
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-851-5511
kkimura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Kimura |
Organization
Graduate School of Medical Sciences, Nagoya City University
Division name
Department of Clinical Pharmacy
Zip code
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-851-5511
Homepage URL
kkimura@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
KYOWA HAKKO BIO CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 12 | Month | 25 | 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
| 2014 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 24 | Day |
Last modified on
| 2018 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018654
