UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012512 |
|---|---|
| Receipt number | R000014645 |
| Scientific Title | Evaluation of the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder. |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2013/12/06 19:42:56 |
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Basic information
Public title
Evaluation of the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.
Acronym
Evaluation of the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.
Scientific Title
Evaluation of the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.
Scientific Title:Acronym
Evaluation of the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
change of frequency of urination in 24 hours
Key secondary outcomes
change of urinary urgency in 24 hours, change of urinary incontinence in 24 hours, change of OABSS score, change of KHQ score, Residual urine volume, adverse event
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
Propiverine hydrochloride(BUP-4) 20mg will be orally administered once day after breakfast after observation period(2days)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Female Patients diagnosed as overactive bladder.
2) 20 years old or more patients,
3) Residual urine volume is less than 50mL
Key exclusion criteria
1) Patients with bladder stone, urethral calculus, interstitial cystitis
2) Patients with endometriosis required for surgery and pelvic organ prolapse
3) Patients with history of treatment OAB within 2 months
4) Patients with treatment for cancer
5) Patients with lower urinary tract symptom
6) Patients with symptomatic urinary tract infection
7) Patients with polyuria (>=3000mL /day)
8) Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled hypertension)
9) Patients with angle-closure glaucoma
10) Patients with severe heart dysfunction, renal dysfunction, liver dysfunction
11) Women who are capable of pregnancy, intend to get pregnant
12) Pregnant or lactating women
13) Judged ineligible based on physicians' decision
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yousuke Tsukinaga |
Organization
Maruyama Memorial General Hospital
Division name
Department of Urology
Zip code
Address
Hon-tyo 1981, Iwatsuki-ku, Saitama-shi, Saitama 339-8521, Japan
TEL
048-757-3511
tsuky1979@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Washino |
Organization
Jichi Saitama Medical Center
Division name
Department of Urology
Zip code
Address
Amanuma-tyo 1-847, Oomiya-ku, Saitama-shi, Saitama 330-8503, Japan
TEL
048-647-2111
Homepage URL
suwajiisan@jichi.ac.jp
Sponsor or person
Institute
Saitama Continence Conference
Institute
Department
Personal name
Funding Source
Organization
Saitama Continence Conference
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | 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
| 2013 | Year | 12 | Month | 06 | Day |
Last modified on
| 2013 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014645
