UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013084 |
|---|---|
| Receipt number | R000015199 |
| Scientific Title | Fesoterodine ameliorates the activity in frontal brain micturition area and the hypersensibility of bladder afferent nerves in patients with OAB symptoms. |
| Date of disclosure of the study information | 2014/02/15 |
| Last modified on | 2014/02/05 18:35:12 |
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Basic information
Public title
Fesoterodine ameliorates the activity in frontal brain micturition area and the hypersensibility of bladder afferent nerves in patients with OAB symptoms.
Acronym
Fesoterodine ameliorates frontal activity and OAB symptoms
Scientific Title
Fesoterodine ameliorates the activity in frontal brain micturition area and the hypersensibility of bladder afferent nerves in patients with OAB symptoms.
Scientific Title:Acronym
Fesoterodine ameliorates frontal activity and OAB symptoms
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate ameliorating of the de-activation in frontal micturition area and the hypersensibility of bladder afferent nerves in patients with overactive bladder (OAB) symptoms before and after treatment with fesoterodine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of oxy-hemoglobin concentration in frontal micturition area of subjects before and after treatment with fesoterodine (from Baseline to value after 12 weeks of treatment).
Key secondary outcomes
Change of CPT in bladder afferent nerves of subjects before and after treatment with fesoterodine (from Baseline to value after 12 weeks of treatment).
A multiple correlation of improving among urgency symptom, oxy-hemoglobin concentration in frontal micturition area and CPT in bladder afferent nerves in subjects before and after treatment with fesoterodine.
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
3 months administration of fesoterodine (4mg/day or 8mg/day flexibly updosed after initial 4 weeks observation)
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
Male and Female
Key inclusion criteria
Subject who received Informed consent and signed informed consent form.
Subject has >=6 in OABSS total score and >=3 in sub score, Q3 of OABSS at screening.
Subject who is moderate and more in OAB severity.
Subject is male or female patients >=20 years old.
Subject who reported overactive bladder symptoms 3 months or greater in duration at Visit 1.
Subject who is able and willing to complete all study related assessment tools and complied with scheduled clinic visits and clinical study procedures.
Key exclusion criteria
Subject who had a known disorder that damages a spinal cord (e.g., spinal cord injury, lumbar spondylosis, spina bifida etc.).
Subjects with indwelling catheter or who require the clean intermittent catheterization(CIC)
Subject who had a residual urine volume (sonographic) >100 mL, or a prostate size >30 ml at Visit 1.
Subject who had a complication of lower urinary tract pathology potentially responsible for urgency or incontinence (e.g., bladder stone, interstitial cystitis, urothelial tumors etc.), clinically relevant bladder outlet obstruction (e.g., benign prostatic hypertrophy etc.)
Subject who had an active urinary tract infection (UTI) as shown by the results of the urinalysis at Visit 1 or recurrent urinary tract infection defined as treatment for UTI >=3 times in the last year.
Subject who was known to have polyuria (>3000 mL/24h).
Subject who had been treated with OAB treatment agents, such as antimuscarinic drugs within 2 weeks prior to Visit 1.
Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuji Sakakibara |
Organization
Sakura Medical Center, Toho University
Division name
Neurology
Zip code
Address
564-1 Shimoshizu, Sakura, 285-8741 Japan
TEL
043-462-8811
sakakibara@sakura.med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuji Sakakibara |
Organization
Sakura Medical Center, Toho University
Division name
Neurology
Zip code
Address
564-1 Shimoshizu, Sakura, 285-8741 Japan
TEL
043-462-8811
Homepage URL
http://www.lab.toho-u.ac.jp/med/sakura/neurology/
sakakibara@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Neurology, Sakura Medical Center, Toho University
Institute
Department
Personal name
Funding Source
Organization
Neurology, Sakura Medical Center, Toho University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
東邦大学医療センター佐倉病院神経内科
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.lab.toho-u.ac.jp/med/sakura/neurology/
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 | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 05 | Day |
Last modified on
| 2014 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015199
