UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010628 |
|---|---|
| Receipt number | 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 12:01:26 |
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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
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
Sponsor or person
Institute
Kobe University Graduate of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012427
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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