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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003290
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokyo Woman's Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003984

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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