A Study of the Antipruritic Effect and Onset of Sleepiness with Oral Antihistamines -Comparison of sedative and non-sedative antihistamine
Not Applicable
- Conditions
- atopic dermatitis,chronic urticaria and pruritus
- Registration Number
- JPRN-UMIN000003290
- Lead Sponsor
- Tokyo Woman's Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and severity of sleepiness (JESS score)
- Secondary Outcome Measures
Name Time Method 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