UMIN-CTR Clinical Trial

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

Overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Suzuka University of Medical Science

Institute

Department

Personal name

Organization

Suzuka University of Medical Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2017

Year

12

Month

16

Day

Last modified on

2017

Year

12

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034738