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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011611
Receipt No. 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

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Basic information
Public 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
Acronym 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
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
Scientific Title:Acronym 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
Region
Japan

Condition
Condition Stress urinary incontinence
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes -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
Key secondary outcomes Safety of magnetic stimulator, urodynamics equipment, and administration of Duloxetine.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 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)
Interventions/Control_2 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.
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 Female
Key inclusion criteria 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
Key exclusion criteria 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.
Target sample size 10

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 861-4157,Japan
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 861-4157,Japan
TEL 096-358-1116
Homepage URL
Email m-yonou@nishikuma.com

Sponsor
Institute Medical Co. LTA Nishikumamoto Hospital
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Other
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 医療法人相生会 にしくまもと病院(熊本県)

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 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.
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
2013 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 31 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=R000013582

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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