Unique ID issued by UMIN | UMIN000011611 |
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Receipt number | R000013582 |
Scientific Title | A Double-Blind, Single-Dose, 2-period Crossover Exploratory Study to Evaluate the Effects of Single Oral Dose of Duloxetine on Urethral Pressure in Japanese Female Patients with Stress Urinary Incontinence |
Date of disclosure of the study information | 2013/09/17 |
Last modified on | 2014/07/08 13:00:14 |
A Double-Blind, Single-Dose, 2-period Crossover Exploratory Study to Evaluate the Effects of Single Oral Dose of Duloxetine on Urethral Pressure in Japanese Female Patients with Stress Urinary Incontinence
A Double-Blind, Single-Dose, 2-period Crossover Exploratory Study to Evaluate the Effects of Single Oral Dose of Duloxetine on Urethral Pressure in Japanese Female Patients with Stress Urinary Incontinence
A Double-Blind, Single-Dose, 2-period Crossover Exploratory Study to Evaluate the Effects of Single Oral Dose of Duloxetine on Urethral Pressure in Japanese Female Patients with Stress Urinary Incontinence
A Double-Blind, Single-Dose, 2-period Crossover Exploratory Study to Evaluate the Effects of Single Oral Dose of Duloxetine on Urethral Pressure in Japanese Female Patients with Stress Urinary Incontinence
Japan |
Stress urinary incontinence
Urology |
Others
NO
The objective of this exploratory study is to evaluate the effects of single oral dose of duloxetine on urethral pressure under transcranial magnetic stimulation (TMS), sacral root magnetic stimulation (SMS) and cough stimulation in Japanese female patients with SUI, adopting a randomized double-blind single-dose 2-period crossover design
Pharmacodynamics
Exploratory
Not applicable
-Intensity (threshold) of TMS causing urethral sphincter contraction (elevation in urethral pressure)
-Urethral pressure measured under SMS
-Urethral pressure measured under cough stimulation
-Leak Point Pressure (LPP)
-Volume of incontinence in the 20-minute pad test
Safety of magnetic stimulator, urodynamics equipment, and administration of Duloxetine.
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
YES
No need to know
2
Prevention
Medicine |
Measurement of urethral, and bladder pressure in response to transcranial, sacral root magnetic and cough stimulation using micro-tip transducer catheter, before and after single oral administration of duloxetine hydrochloride (40 mg on a Duloxetine basis)
Measurement of urethral, and bladder pressure in response to transcranial, sacral root magnetic and cough stimulation using micro-tip transducer catheter, before and after single oral administration of placebo.
20 | years-old | <= |
Not applicable |
Female
At the time of screening
1.In the opinion of the primary investigator or the sub-investigator, the subject is capable of understanding and complying with protocol requirements.
2.The subject is a Japanese female patient with urinary incontinence, who signed the written informed consent, is not pregnant or lactating, and has prevailing symptoms of SUI.
3.The subject is aged 20 or higher 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 has no clinically significant abnormalities in accordance with the study site's criteria and is judged eligible to participate in this study by the investigator.
6.The subject presents symptoms of SUI beginning 3 months or more before consent acquisition.
7.The subject experiences SUI once or more per week.
8.The subject is positive in one-hour pad test.
9.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.
On the day of medication
1.The subject presents symptoms of SUI beginning 3 months or more before consent acquisition.
2.The subject experiences SUI once or more per week
Subject who/with
-received study drug within 16 weeks before the study.
-is related to the study site or its employees, or may consent under duress.
-a history of disease considered to be unsuitable for the study.
-a history of convulsive disease and/or cardiac arrhythmias.
-carries an implant type medical device.
-an indwelling magnetic body in the cranial cavity.
-a history of gastrointestinal surgery that may affect the drug absorption, or a history of surgery for intrapelvic organ that may injure nerve related to lower urethra or other nerve.
-has chronic urinary tract infection or has had an episode within 4 weeks or evidence of current urinary tract infection.
-is hypersensitive to drugs including duloxetine and levofloxacin.
-has taken any medication that may affect the urinary tract function.
-has a history of alcohol abuse within 52 weeks prior and is unable to abstain from alcohol during the study.
-has a positive test result for HBsAg, HCV, HIV antibody/antigen or syphilis.
-smokes excessively routinely (unable to refrain from smoking during the hospitalization).
-has donated blood component within 2 weeks , or received blood collection in a volume exceeding 200 mL within 4 weeks or in a volume exceeding 400 mL within 12 weeks before hospitalization.
-has a history of drug therapy for urinary incontinence within 3 months.
-the pelvic floor muscles training has not stabilized or may not stabilize during the study period.
-is a patient with urinary incontinence in whom symptoms of urge incontinence are prevailing.
-has a supine blood pressure over 140 mm Hg for systolic, or 90 mm Hg for diastolic, or is taking medication for hypertention.
-is considered unsuitable for this study by the principal investigator or the sub-investigator.
10
1st name | |
Middle name | |
Last name | Makoto Yono |
Medical Co. LTA Nishikumamoto Hospital
Clinical Pharmacology Department
1012 Koga, Tomiai-machi, Minami-ku, Kumamoto-shi,Kumamoto 861-4157,Japan
096-358-1116
m-yonou@nishikuma.com
1st name | |
Middle name | |
Last name | Makoto Yono |
Medical Co. LTA Nishikumamoto Hospital
Clinical Pharmacology Department
1012 Koga, Tomiai-machi, Minami-ku, Kumamoto-shi,Kumamoto 861-4157,Japan
096-358-1116
m-yonou@nishikuma.com
Medical Co. LTA Nishikumamoto Hospital
Takeda Pharmaceutical Company Limited
Other
NO
医療法人相生会 にしくまもと病院(熊本県)
2013 | Year | 09 | Month | 17 | Day |
Unpublished
Single oral administration of duloxetine significantly increased the mean and maximal urethral pressures at rest over the proximal, middle and distal third of the urethra. During coughing, duloxetine significantly increased the mean distal urethral pressure.
All adverse events were mild and were resolved without further treatments.
Completed
2013 | Year | 08 | Month | 14 | Day |
2013 | Year | 09 | Month | 02 | Day |
2013 | Year | 08 | Month | 31 | Day |
2014 | Year | 07 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013582
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