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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001761
Receipt No. 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

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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
Email

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
Email tom-nobu@muf.biglobe.ne.jp

Sponsor
Institute Kyoto City Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002120

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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