UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003290 |
|---|---|
| Receipt number | R000003984 |
| Scientific Title | A Study of the Antipruritic Effect and Onset of Sleepiness with Oral Antihistamines -Comparison of sedative and non-sedative antihistamine- |
| Date of disclosure of the study information | 2010/03/05 |
| Last modified on | 2011/04/21 17:45:34 |
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Basic information
Public title
A Study of the Antipruritic Effect and Onset of Sleepiness with Oral Antihistamines
-Comparison of sedative and non-sedative antihistamine-
Acronym
A Study of the Antipruritic Effect and Onset of Sleepiness with Oral Antihistamines
Scientific Title
A Study of the Antipruritic Effect and Onset of Sleepiness with Oral Antihistamines
-Comparison of sedative and non-sedative antihistamine-
Scientific Title:Acronym
A Study of the Antipruritic Effect and Onset of Sleepiness with Oral Antihistamines
Region
| Japan |
Condition
Condition
atopic dermatitis,chronic urticaria and pruritus
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sedative and non-sedative antihistamines are to be administered in a crossover method to patients suffering from chronic skin diseases accompanied by atopic dermatitis, chronic urticaria, and pruritus to study the incidence and degree of sleepiness developing with each of the drugs. Efficacy against itching and efficacy against the primary disease will also be compared between drugs, along with QOL and drug safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence and severity of sleepiness (JESS score)
Key secondary outcomes
1) NRS scoring for pruritus.
2) NRS scoring for sleepiness.
3) QOL with relation to skin diseases (Skindex-16).
4) Evaluation of severity of atopic dermatitis and evaluation of severity of pruritus in other skin diseases.
5) Safety
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bepotastine besilate(14days),Wash out(7days) and d-Chlorpheniramine Maleate or Ketotifen(14days)
Interventions/Control_2
d-Chlorpheniramine Maleate or Ketotifen(14days),Wash out(7days) and Bepotastine besilate(14days)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who were diagnosed with atopic dermatitis, chronic urticaria, and pruritus
2) Patients who were scored NRS 3<= for pruritus
3) Patients who gave their written informed consent
Key exclusion criteria
1)Patients who have the history of hypersensitivity to any of the study drug
2)Patients who had been taking an anti-histamine drug within 7 days before the registration
3)Patients who are pregnant,might be pregnant, lactating ,or wishing a pregnancy during the study period.
4)Patients who are complaining of sleepiness due to the influence of a regularly used drug that is not an antihistamine
5)Patients who are commonly complaining of intense sleepiness
6)Patients who are considered unsuitable for this study by the investigator
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Kawashima/Yoshiki Miyachi |
Organization
Tokyo Woman's Medical University/
Kyoto University Graduate School of Medicine
Division name
Dermatology/ Dermatology
Zip code
Address
8-1 Kawada-cho Shinjuku-ku, Tokyo 162-8666,Japan/54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
EBMs Co.,Ltd
Division name
Clinical Business Division
Zip code
Address
TEL
03-5777-1001
Homepage URL
Sponsor or person
Institute
Tokyo Woman's Medical University
Institute
Department
Personal name
Funding Source
Organization
Non-Profit Organization Health Institute Research of Skin
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
| 2010 | Year | 03 | Month | 05 | 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
Completed
Date of protocol fixation
| 2009 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 05 | Day |
Last modified on
| 2011 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003984
