UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008406 |
|---|---|
| Receipt number | R000009889 |
| Scientific Title | A double-blind cross-over study comparing the effects of single doses of fexofenadine, olopatadine, ketotifen fumarate and placebo on sedation in healthy Japanese subjects |
| Date of disclosure of the study information | 2012/07/11 |
| Last modified on | 2013/01/11 10:55:17 |
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Basic information
Public title
A double-blind cross-over study comparing the effects of single doses of fexofenadine, olopatadine, ketotifen fumarate and placebo on sedation in healthy Japanese subjects
Acronym
A study comparing the effects of anti histamine on sedation
Scientific Title
A double-blind cross-over study comparing the effects of single doses of fexofenadine, olopatadine, ketotifen fumarate and placebo on sedation in healthy Japanese subjects
Scientific Title:Acronym
A study comparing the effects of anti histamine on sedation
Region
| Japan |
Condition
Condition
Healthy male subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of single oral doses of fexofenadine and olopatadine, ketotifen fumarate on objective measures of daytime sleepiness, psychomotor performance and subjective assessments of sedation in healthy Japanese subjects.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleepiness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
fexofenadine
Interventions/Control_2
olopatadine
Interventions/Control_3
ketotifen fumarate
Interventions/Control_4
placebo
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
- Those who have the ability to provide written informed consent to participate in the study.
- Healthy males aged between 20 and 40 years.
- Body weight between 50 and 100 kg, and a body mass index (BMI) between 18 and 32 kg/m2.
Key exclusion criteria
-Any anaphylaxis with fexofenadine, olopatadine or ketotifen fumarate.
-Any renal or hepatic disease requiring treatment.
-Any convulsive disease or disease requiring treatment.
-Any hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
-QT prolongation over 460 ms.
-Use of any medicine or health product that contains Saint John's wort within 7 days before dosing.
- Intake of fruit juice containing grapefruit juice or orange juice within 7 days before dosing.
- Participation in any other clinical reseach in the past 3 months.
- Donating over 200 ml of blood within the past 1 month or over 400 ml of blood within the past 3 months.
- Poorly controlled arterial hypertension (Systolic blood pressure >160mmHg and/or diastolic blood pressure >100mmHg)
- Positive HIV antibody, VDRL(quality), HBs antigen or HCV antibody.
- Positive drug screening.
- Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
Target sample size
16
Research contact person
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
2-1-1Asamizodai, Minami, Sagamihara, Kanagawa,
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato University East Hospital
Division name
Clinical trial Center
Zip code
Address
TEL
042-748-9111
Homepage URL
Sponsor or person
Institute
Clinical trial Center,Kitasato University East Hospital
Institute
Department
Personal name
Funding Source
Organization
Clinical trial Center,Kitasato University East Hospital
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
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
| 2012 | Year | 07 | Month | 11 | 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
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | 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
| 2012 | Year | 07 | Month | 11 | Day |
Last modified on
| 2013 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009889
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
