UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020369 |
|---|---|
| Receipt number | R000023411 |
| Scientific Title | A Randomized, Open-Label, Multicenter study evaluating efficacy of switch from dutasteride to tadalafil in benign prostatic hyperplasia patient with lower urinary tract symptoms |
| Date of disclosure of the study information | 2016/01/20 |
| Last modified on | 2018/12/29 09:18:11 |
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Basic information
Public title
A Randomized, Open-Label, Multicenter study evaluating efficacy of switch from dutasteride to tadalafil in benign prostatic hyperplasia patient with lower urinary tract symptoms
Acronym
Switch from dutasteride to tadalafil in patent with benign prostatic hyperplasia
Scientific Title
A Randomized, Open-Label, Multicenter study evaluating efficacy of switch from dutasteride to tadalafil in benign prostatic hyperplasia patient with lower urinary tract symptoms
Scientific Title:Acronym
Switch from dutasteride to tadalafil in patent with benign prostatic hyperplasia
Region
| Japan |
Condition
Condition
benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is a randomized, open-label, multinational, 12-week study to evaluating switching effect from dutasteride to tadalafil in benign prostatic hyperplasia patients with lower urinary tract symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS)
Key secondary outcomes
Change from Baseline to 12 Week Endpoint in IPSS Irritative Subscore, IPSS Voiding (Obstructive) Subscore, IPSS Quality of Life (QoL) Index, Uroflowmetry Parameter: Peak Flow Rate (Qmax), Number of Participants With Adverse Events International Index of Erectile Function (IIEF), Blood Pressure,ostvoid Residual Volume (PVR), Prostate Specific Antigen (PSA),testosterone, oxygen stress
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tadalafil 5mg one a day, for 12 weeks
Interventions/Control_2
No treatment, observation for 12 weeks
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
| 99 | years-old | >= |
Gender
Male
Key inclusion criteria
Males, 20 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms who were taking dutasteride
Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study
Have not taken phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 1.
Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.
Key exclusion criteria
Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
Clinical evidence of prostate cancer at Visit 1.
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikara Ohyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
5 Zaifu-chou, Hirosaki, Japan
TEL
+81172395091
shingorilla2@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Hatakeyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
5 Zaifu-chou, Hirosaki, Japan
TEL
+81172395091
Homepage URL
shingorilla2@gmail.com
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
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
| 2016 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2016 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 29 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 29 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 27 | Day |
Last modified on
| 2018 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023411
