UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001761 |
|---|---|
| Receipt number | R000002120 |
| Scientific Title | Evaluation the relationship of LUTS and urine pH, and efficacy of the citrates in patients with LUTS. |
| Date of disclosure of the study information | 2009/03/09 |
| Last modified on | 2013/03/29 17:33:45 |
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Basic information
Public title
Evaluation the relationship of LUTS and urine pH, and efficacy of the citrates in patients with LUTS.
Acronym
Safety and efficacy of the citrates in patients with LUTS.
Scientific Title
Evaluation the relationship of LUTS and urine pH, and efficacy of the citrates in patients with LUTS.
Scientific Title:Acronym
Safety and efficacy of the citrates in patients with LUTS.
Region
| Japan |
Condition
Condition
LUTS
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship of LUTS and urine pH, safety and efficacy of the citrates in patients with LUTS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary frequency, pain, QOL (King's health questionnaire, ICSI, ICPI)
Key secondary outcomes
Quality of sleep (Pittsburg sleep quality index, Epworth sleepiness scale)
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 citrates 1 gram X 3 per day orally, four weeks. (if dose increased, four more weeks.)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with LUTS ,age >=20 years.
2) Signed and dated informed consent document indicating that patient has been informed of all pertinent aspects of this trial prior to enrollment.
3) Patients who are observed acidic urine and pain of LUT in their voiding diary, will be enrolled into the treatment phase.
Key exclusion criteria
1) Urinary tract infection.
2) Urinary calculus or bladder calculus.
3) Prostate cancer.
4) Bladder tumor.
5) Grossly bloody urine of unknown cause.
6) Serious liver disease or kidney disease.
7) Women who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
8) Patients who are judged unfit to enroll in this trial by the investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Ueda |
Organization
Kyoto City Hospital
Division name
Department of Urology
Zip code
Address
1-2 Higashitakada-cho, Mibu, Nakagyo-ku, Kyoto.
TEL
075-311-5311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Ueda |
Organization
Kyoto City Hospital
Division name
Department of Urology
Zip code
Address
1-2 Higashitakada-cho, Mibu, Nakagyo-ku, Kyoto.
TEL
075-311-5311
Homepage URL
tom-nobu@muf.biglobe.ne.jp
Sponsor or person
Institute
Kyoto City Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto City Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
NPO Comfortable Urology Network
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
| 2009 | Year | 03 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 09 | Day |
Last modified on
| 2013 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002120
