UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009096 |
|---|---|
| Receipt number | 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 12:57:02 |
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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
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
m-yonou@nishikuma.com
Sponsor or person
Institute
Medical Co. LTA Nishikumamoto Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010671
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