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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013084
Receipt No. 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

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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
Email 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/
Email sakakibara@sakura.med.toho-u.ac.jp

Sponsor
Institute Neurology, Sakura Medical Center, Toho University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015199

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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