UMIN-CTR Clinical Trial

Public title

A double blind,placebo controlled single-dose, crossover study to evaluate the pharmacokinetic and pharmacodynamic profiles of scoplamine in healthy male subjects

Acronym

A placebo controlled crossover study to evaluate the pharmacokinetic and pharmacodynamic profiles of scoplamine in healthy male subjects

Scientific Title

A double blind,placebo controlled single-dose, crossover study to evaluate the pharmacokinetic and pharmacodynamic profiles of scoplamine in healthy male subjects

Scientific Title:Acronym

A placebo controlled crossover study to evaluate the pharmacokinetic and pharmacodynamic profiles of scoplamine in healthy male subjects

Region

Japan

Condition

amyotrophic lateral sclerosis

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To explore the pharmacokinetics of Scoplamine ointment (5%) in healthy male subjects applied to post-auricular area once a daily with an adhesive plaster

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

Pharmacokinetics
Plasma concencentrations of unchanged Scopolamin, urinary excretion rates and pharmacokinetic parameters (Cmax, Tmax, AUC and halflife time)

Key secondary outcomes

Study type

Interventional

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

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Period1:The subjects were treated Scopolamin ointment(5%)in applied to post-auricular area once a daily with an adhesive plaster-wash-out period(more than one week)-Period2: The subjects were treated placebo (hydrophilic ointment) in applied to post-auricular area once a daily with an adhesive plaster

Interventions/Control_2

Period1: The subjects were treated placebo (hydrophilic ointment) in applied to post-auricular area once a daily with an adhesive plaster- wash-out period (more than one week)-Period2: The subjects were treated Scopolamin ointment(5%)in applied to post-auricular area once a daily with an adhesive plaster

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

20

years-old

<=

Age-upper limit

40

years-old

>

Gender

Male

Key inclusion criteria

Subjects eligible for inclusion in this study have to fulfill all of following criteria and be judged eligible for the study by the investigator
1)Subjects must be able to understand the requirement of the study and must give a written, signed and dated informed consent before any study related activity is performed
2)Male subjects aged older than 20 and younger than 40 years old at timing of giving written informed consent
3)Subjects must be 50-100kg in weight and 18-27kg/m2 in BMI
4)Subjects must be judged eligible for inclusion in the study by the investigator after examining the investigators interview, physical and laboratory test

Key exclusion criteria

Subjects will be excluded from enrollment by the following criteria. The investigator must ensure the criteria basically at the timing of screening.
1) Subjects who have history of hypersensitivity to Scopolamin /Atropin (Belladonna alcaloid)
2) Subjects who are prohibited the use of Scopolamin hydrobromide as follows ;
(a) glaucoma
(b)Prostatic hypertorophy with dysuria
(c)Clinical significant heart disease
(d)Paralytic ileus
(e)A known hypersensitivity to the study drug or the ingredient of the study drug
(f)History or clinical evidence of Asthma
(g)History or clinical evidence of Hepatitis
3) Subjects with underlyimg condition (renal or hepatic ) that need treatment
4)Subjects may be administrated anticholinergic agent or dopaminergic antagonist during this study, the opinion of the investigator would not be judged eligible for the enrollment of this study
5)Subjects that in the opinion of the investigator would not be judged eligible for the enrollment of the study based on the mode of action of the investigational drug
6)Subjects took a drug containing Scopolamin or health food containing St.Johns wort within 14days before dosing and be judged not eligible for the enrollment of the study by the investigator
7) Subjects who took food and drink containing grapfruits 7 days prior to dosing
8) Use of investigational treatment within 3 months before the time of enrollment
9) Domation or loss of 200 mL or more blood within a month prior to participation, domation or loss of 400 mL or more blood within 3 months prior to participation
10) A positive Syphilis test result, Hepatitis B surface antigen or Hepatitis C
11) History of drug or alcohol abuse or evidence of such abuse as indicated by the laboratory assays conducted the screening or baseline evaluations.
12) Subjects that in the opinion of the investigator would not be judged eligible for the enrollment of the study

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Yuji Kumagai

Organization

Kitasato University East Hospital

Division name

Clinical Trial Center

Zip code

Address

2-1-1, Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan

TEL

+81-42-748-9111

Email

kuma-guy@za2.so-net.ne.jp

Name of contact person

1st name
Middle name
Last name	Mika Maeda

Organization

Kitasato University East Hospital

Division name

Clinical Trial Center

Zip code

Address

2-1-1, Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan

TEL

+81-42-748-9111

Homepage URL

Email

m-maeda@kitasato-u.ac.jp

Institute

Clinical Trial Center , Kitasato University East Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

北里大学東病院（神奈川県）

Date of disclosure of the study information

2013

Year

12

Month

13

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

2013

Year

10

Month

07

Day

Date of IRB

Anticipated trial start date

2013

Year

11

Month

06

Day

Last follow-up date

2013

Year

12

Month

17

Day

Date of closure to data entry

2014

Year

02

Month

28

Day

Date trial data considered complete

2014

Year

03

Month

31

Day

Date analysis concluded

2014

Year

05

Month

31

Day

Other related information

Registered date

2013

Year

12

Month

13

Day

Last modified on

2015

Year

06

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014674