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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003125
Receipt No. R000003733
Scientific Title CLSS-based assessment of alfa-adrenoceptor blockers for male LUTS (CLAM-STUDY)
Date of disclosure of the study information 2010/02/01
Last modified on 2019/02/08

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Basic information
Public title CLSS-based assessment of alfa-adrenoceptor blockers for male LUTS (CLAM-STUDY)
Acronym CLAM-STUDY
Scientific Title CLSS-based assessment of alfa-adrenoceptor blockers for male LUTS (CLAM-STUDY)
Scientific Title:Acronym CLAM-STUDY
Region
Japan

Condition
Condition male lower urinary tract symptoms, mLUTS
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to evaluate the efficacy and safety of alfa-adrenoceptor blockers for male lower urinary tract symptoms (mLUTS) using the new CLSS evaluation index and to determine any correlation between CLSS and other conventional evaluation indices (International prostate symptom score (I-PSS) and Overactive baldder symptom score (OABSS)).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Results of treatment with silodosin or tamsulosin hydrochloride evaluated by variations in the new CLSS evaluation index (total score and category-specific score).
Key secondary outcomes I-PSS, OABSS, Uroflowmetry, Residual urine volume, Prostate volume

Base
Study type Interventional

Study design
Basic design Parallel
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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Silodosin 8 mg dairy
Interventions/Control_2 Tamsulosis 0.2 mg dairy
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Male patients with newly diagnosed LUTS according to the treatment algorithm of the Clinical Practice Guidelines for Male Lower Urinary Tract Symptoms
Key exclusion criteria Patients who meet any of the following criteria are excluded:
1) Patients taking anticholinergic agents, antidepressants, or antianxiety agents
2) Patients with a history of urinary retention, urinary tract infections, macroscopic haematuria, lower urinary tract surgery, radiotherapy for the pelvic organs, or neurologic disease
3) Patients with pyuria, renal impairment, calculus bladder, or who are urine cytology positive
4) Patients with elevated PSA levels (4.0 ng/mL or over)
5) Patients whose 9th CLSS score is 2 or higher
6) Patients who are not willing to receive drug treatment
7) Patients who cannot answer the questionnaire by themselves
8) Patients classified as ineligible by the investigator
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Homma
Organization The University of Tokyo Hospital
Division name Department of Urology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL +81-3-5800-8662
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motofumi Suzuki
Organization The University of Tokyo Hospital
Division name Department of Urology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL +81-3-5800-8662
Homepage URL http://www.h.u-tokyo.ac.jp/urology/
Email SUZUKIM-URO@h.u-tokyo.ac.jp

Sponsor
Institute Department of Urology, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kamijyo Clinic, Meirikai Chuo General Hospital, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Tokyo Kyosai Hospital, Toshiba Hospital, etc.
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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 01 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 Terminated
Date of protocol fixation
2009 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 01 Day
Last modified on
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003733

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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