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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030425
Receipt No. R000034738
Scientific Title Clinical study about application site reaction in the oxybutynin transdermal patch
Date of disclosure of the study information 2017/12/17
Last modified on 2017/12/17

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Basic information
Public title Clinical study about application site reaction in the oxybutynin transdermal patch
Acronym Clinical study about application site reaction in the oxybutynin transdermal patch
Scientific Title Clinical study about application site reaction in the oxybutynin transdermal patch
Scientific Title:Acronym Clinical study about application site reaction in the oxybutynin transdermal patch
Region
Japan

Condition
Condition Overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the combination of the heparinoid cream is useful for the application site reaction of the oxybutynin transdermal patch
Basic objectives2 Others
Basic objectives -Others Comparison of the skin barrier function
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of skin barrier function

Evaluation of overactive bladder symptom score
Key secondary outcomes Evaluation of skin barrier function
The skin condition of the lower abdomen, femoral area, and lower back of the participants was evaluated before application of heparinoid cream and oxybutynin transdermal patches. Skin hydration and TEWL were evaluated using Corneometer CM825 and Tewameter TM300 core
Severity of OAB was determined by OABSS. OABSS was assessed every 2 weeks from the start of oxybutynin transdermal patch treatment (week 2). OABSS decrease of >3 points during treatment period was considered effective treatment in accordance with the evaluation method described by Gotoh et al.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
65 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients diagnosed with overactive bladder
2) Patients who can provide written informed consent to participate in the study
Key exclusion criteria 1)uroschesis
2)closed-angle glaucoma
3)pylorus, duodenum or intestinal tract blockage
4)paralytic ileus
5)gastric or intestinal atony
6)myasthenia gravis
7)history of oxybutynin hydrochloride hypersensitivity were excluded
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kazuya Ooi
Organization Suzuka University of Medical Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 3500-3, Minamitamagakicho, Suzuka-shi, Mie, 513-8670
TEL 059-340-0550
Email zooi@suzuka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihito Murakami
Organization Sunai Pharmacy Co., Ltd.
Division name Kuwana pharmacy
Zip code
Address 3-25, Kotobukicho, Kuwana-shi, Mie, 511-0061
TEL 0594-84-7735
Homepage URL
Email yoshihitomurakami5515@gmail.com

Sponsor
Institute Suzuka University of Medical Science
Institute
Department

Funding Source
Organization Suzuka University of Medical Science
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

Other administrative information
Date of disclosure of the study information
2017 Year 12 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
Application of heparinoid cream increased skin hydration without altering transepidermal water loss. No obvious application site reaction was observed during treatment with oxybutynin transdermal patch. Overactive bladder symptom score significantly decreased during treatment (70% of patients showed a decrease of > 3 points after 12 weeks).
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
2016 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 08 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
2016 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information This prospective observational study was performed at the Nagae Prostate Care Clinic. 1. After selection of participants according to the eligibility criteria described in the Participants subsection, heparinoid cream (Hirudoid soft ointment; Maruho Co., Ltd., Japan) was applied to the skin for 13 weeks. Before application of the heparinoid cream and oxybutynin transdermal patch (NEOXY TAPE 73.5 mg; Hisamitsu Pharmaceutical Co., Inc., Japan), skin hydration and transepidermal water loss (TEWL) were evaluated at the application site. Oxybutynin transdermal patch was applied for 12 weeks, and efficacy and adherence were evaluated every 2 weeks.

Management information
Registered date
2017 Year 12 Month 16 Day
Last modified on
2017 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/12/17 症例データレポジトリ.xlsx


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