UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021468 |
|---|---|
| Receipt number | R000024764 |
| Scientific Title | The effect on stone expulsive rate and the safety of Tadarafil in urolithiasis patients. |
| Date of disclosure of the study information | 2016/03/15 |
| Last modified on | 2016/03/14 21:59:24 |
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Basic information
Public title
The effect on stone expulsive rate and the safety of Tadarafil in urolithiasis patients.
Acronym
Effect of Tadarafil in urolithiasis patients.
Scientific Title
The effect on stone expulsive rate and the safety of Tadarafil in urolithiasis patients.
Scientific Title:Acronym
Effect of Tadarafil in urolithiasis patients.
Region
| Japan |
Condition
Condition
Urolithiasis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the stone expulsive rate and safety of Tadarafil in urolithiasis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Stone expulsive rate
Key secondary outcomes
Time to stone expulsion, use of analgesia and adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard treatment (Tiquijium bromide + dicrofenac)
Interventions/Control_2
Standard treatment +Tadarafil 2.5mg
Interventions/Control_3
Standard treatment +Tadarafil 5mg
Interventions/Control_4
Standard treatment +Tadarafil 10mg
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
Urolithiasis patients with its diameter of 6 mm or less. Patients should be 20 years-old or older.
Written consent should be acquired from the patients.
Key exclusion criteria
1) patients taking alpha1 receptor blocker
2) patients taking anti cholinergic agents
3) patients taking steroidal agents
4) pregnant women
5) patients with multiple ureteral stones
6) patients treated with NO donor
7) patients treated with Riociguat
8) patients with unstable angina, heart failure (over NYHA grade III), uncontrolled arrhythmia, hypotension (<90/50mmHg), uncontrolled hypertension (>170/100mmHg), cardiac infarction within last three months, cerebral hemorrhage /infarction with in last six months
9) patients with severe renal failure
10) patients with severe liver failure
11) patients cannot visit hospital for evaluation
12) others that decided inapplicable by principal investigator or sub-investigator
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shibata |
Organization
Gunma University Hospital
Division name
Urology
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan, 371-8511
TEL
027-220-8303
yash@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shibata |
Organization
Gunma University Hospital
Division name
Urology
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan, 371-8511
TEL
027-220-8303
Homepage URL
yash@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
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
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 | 03 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 14 | Day |
Last modified on
| 2016 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024764
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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