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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010628
Receipt No. R000012427
Scientific Title Examination of the efficacy of Chlormadinone Acetate on the Dutasteride resistance Benign Prostatic Hyperplasia.
Date of disclosure of the study information 2013/05/15
Last modified on 2013/05/01

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Basic information
Public title Examination of the efficacy of Chlormadinone Acetate on the Dutasteride resistance Benign Prostatic Hyperplasia.
Acronym Examination of the efficacy of Chlormadinone Acetate on the Dutasteride resistance Benign Prostatic Hyperplasia.
Scientific Title Examination of the efficacy of Chlormadinone Acetate on the Dutasteride resistance Benign Prostatic Hyperplasia.
Scientific Title:Acronym Examination of the efficacy of Chlormadinone Acetate on the Dutasteride resistance Benign Prostatic Hyperplasia.
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Chlormadinone Acetate(CMA) to patients of Dutasteride(DUT) resistance Benign Prostatic Hyperplasia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reduction rate of Prostate Volume
Key secondary outcomes International Prostatic Symptom Score (I-PSS), QOL-Score, maximum urinary flow rate, residual urine volume, blood test(AST, ALT, blood glucose), Adversed Event, tumor marker(serum PSA), free Testosterone

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 Chlormadinone Acetate(CMA)
One year
25 mg per time
2 times per day
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria The BPH patient whose curative effect by DUT was insufficient for one year or more. (Patients who has provided written informed consent)
In addition, the criteria of insufficiency are as followed; prostate gland volume > 30cc, IPSS > 8, QOL score > 2, and rate of maximum urine flow < 15 mL/s.
Key exclusion criteria 1)Patients with suspected prostate cancer by PSA or DRE.
2)Patients with suspected Neurogenic Bladder.
3)Patients with urethral stricture.
4)Patients who gave radiotherapy in the pelvis.
5)Patients with chronic urinary tract infection, active cystitis interstitial.
6)Patients with serious liver damage / liver disease.
7)Patients with heart disease, renal disease or Anamnesis.
8)Diabetic
9)Patients was deemed by the physician as inappropriate to attend.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Fujisawa
Organization Kobe University Graduate of Medicine
Division name Division of Urology, Department of Surgery Related
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-6155
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kobe University Graduate of Medicine
Division name Division of Urology, Department of Surgery Related
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-6155
Homepage URL
Email

Sponsor
Institute Kobe University Graduate of Medicine
Institute
Department

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

Other related organizations
Co-sponsor Shakaihoken Kobe Central Hospital
Kobe City Medical Center West Hospital
Miki City Hospital
Shinko Hospital
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 社会保険神戸中央病院(兵庫県)
神戸市立医療センター西市民病院(兵庫県)
三木市立三木市民病院(兵庫県)
神鋼病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 15 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 Preinitiation
Date of protocol fixation
2013 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2016 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
2013 Year 05 Month 01 Day
Last modified on
2013 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012427

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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