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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009096
Receipt No. R000010671
Scientific Title Establishment of the Method for Measuring Urethral Sphincter Contraction and Urethral Pressure in Response to Transcranial and Sacral Root Magnetic Stimulation, and the Evaluation of the Effect of a Single Oral Dose of Duloxetine on Urethral Pressure in Healthy Adult Japanese Females
Date of disclosure of the study information 2013/09/17
Last modified on 2014/07/08

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Basic information
Public title Establishment of the Method for Measuring Urethral Sphincter Contraction and Urethral Pressure in Response to Transcranial and Sacral Root Magnetic Stimulation, and the Evaluation of the Effect of a Single Oral Dose of Duloxetine on Urethral Pressure in Healthy Adult Japanese Females
Acronym Establishment of the Method for Measuring Urethral Sphincter Contraction and Urethral Pressure in Response to Transcranial and Sacral Root Magnetic Stimulation, and the Evaluation of the Effect of a Single Oral Dose of Duloxetine on Urethral Pressure
Scientific Title Establishment of the Method for Measuring Urethral Sphincter Contraction and Urethral Pressure in Response to Transcranial and Sacral Root Magnetic Stimulation, and the Evaluation of the Effect of a Single Oral Dose of Duloxetine on Urethral Pressure in Healthy Adult Japanese Females
Scientific Title:Acronym Establishment of the Method for Measuring Urethral Sphincter Contraction and Urethral Pressure in Response to Transcranial and Sacral Root Magnetic Stimulation, and the Evaluation of the Effect of a Single Oral Dose of Duloxetine on Urethral Pressure
Region
Japan

Condition
Condition Healthy female
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Part1: To establish the method for measuring urethral sphincter contraction and urethral pressure in response to TMS and SMS in healthy adult Japanese females.

Part2: To evaluate the effect of a single oral dose of Duloxetine on urethral pressure in response to TMS and SMS in healthy adult Japanese females, and to confirm reproducibility of the test results reported by Dr. Schurch et al.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Reproducibility of the test results reported by Dr. Schurch et al.
Key secondary outcomes Safety of magnetic stimulator, urodynamics equipment, and administration of Duloxetine.
Accuracy of established method for measuring urethral sphincter contraction and urethral pressure.

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 Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 1.Measurement of urethral, bladder and rectal pressure in response to transcranial and sacral root magnetic stimulation using micro-tip transducer catheter or liquid filling catheter.
2.Administration of single oral dose of duloxetine hydrochloride (40 mg on a Duloxetine basis) (Part2)
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
55 years-old >=
Gender Female
Key inclusion criteria 1. In the opinion of the investigator or the subinvestigator, the subject is capable of understanding and complying with protocol requirements.
2. The subject, who signed the written informed consent, is not pregnant or lactating.
3. The subject is aged 20 to 55, inclusive, at the time of signing the informed consent form.
4. The subject weights at least 45 kg and has BMI between 18.0 and 30.0 kg/m2, inclusive, at Screening.
5. The subject is free of clinically problematic abnormalities in accordance with the criteria of the study site and is judged eligible to participate in this study by the investigator.
6. A subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and 4 weeks (28 days) after the last dose of study medication.
Key exclusion criteria The subject who;
1.received study drug within 16 weeks before participation in this study.
2.is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study or may consent under duress.
3.with a history of disease considered to be unsuitable for this study.
4.with a history of convulsive disease such as epilepsy.
5.is carrying an implant type medical device.
6.has an indwelling magnetic body in the cranial cavity.
7.with a history of gastrointestinal surgery that may affect the drug absorption.
8.has chronic urinary tract infection or has had a recent episode within 4 weeks of Check-in or evidence of current urinary tract infection.
9.has a known hypersensitivity to any related compounds of Duloxetine and
other drugs.
10.has a history of alcohol abuse within 52 weeks prior to Screening or is unwilling to agree to abstain from alcohol throughout the study.
11.has a positive test result for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody/antigen or serological reaction of syphilis at Screening.
12.is excessively smoking routinely (unable to refrain from smoking during the hospitalization).
13.has undergone blood component donation within 2 weeks, or has undergone whole blood collection. of at least 200 mL within 4 weeks or at least 400 mL within 12 weeks prior to Check-in.
14.has a QTcF >470 ms or PR outside the range 120 to 220 ms, based on the mean of ECG values at Screening.
15.has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 50 to 90 mm Hg for diastolic at Screening.
16.has a heart rate outside the range 40 to 100 bpm at Screening.
17.who is unlikely to comply with the protocol or is unsuitable for any other reason in the opinion of the investigator or the subinvestigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Yono
Organization Medical Co. LTA
Nishikumamoto Hospital
Division name Clinical Pharmacology Department
Zip code
Address 1012 Koga, Tomiai-machi, Minami-ku, Kumamoto-shi,Kumamoto
TEL 096-358-1116
Email m-yonou@nishikuma.com

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Yono
Organization Medical Co. LTA Nishikumamoto Hospital
Division name Clinical Pharmacology Department
Zip code
Address 1012 Koga, Tomiai-machi, Minami-ku, Kumamoto-shi,Kumamoto
TEL 096-358-1116
Homepage URL
Email m-yonou@nishikuma.com

Sponsor
Institute Medical Co. LTA Nishikumamoto Hospital
Institute
Department

Funding Source
Organization Medical Co. LTA Nishikumamoto Hospital
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/luts.12057/abstract
Number of participants that the trial has enrolled
Results Oral administration of duloxetine significantly increased the mean and maximal urethral closure pressures at the rest over the proximal and middle third of the urethra. During coughing, duloxetine marginally significantly increased the mean distal urethral pressure and significantly reduced the mean delay in the distal urethral pressure peak relative to the vesical peak. Although duloxetine did not change amplitudes of pressure spikes in response to SMS, this drug significantly lowered the MT in response to TMS.
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
2012 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 12 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 12 Day
Last modified on
2014 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010671

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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