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A Study of the Antipruritic Effect and Onset of Sleepiness with Oral Antihistamines -Comparison of sedative and non-sedative antihistamine-

A Study of the Antipruritic Effect and Onset of Sleepiness with Oral Antihistamines -Comparison of sedative and non-sedative antihistamine- - A Study of the Antipruritic Effect and Onset of Sleepiness with Oral Antihistamines

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003290
Enrollment
500
Registered
2010-03-05
Start date
2010-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atopic dermatitis,chronic urticaria and pruritus

Interventions

Bepotastine besilate(14days),Wash out(7days) and d-Chlorpheniramine Maleate or Ketotifen(14days) d-Chlorpheniramine Maleate or Ketotifen(14days),Wash out(7days) and Bepotastine besilate(14days)

Sponsors

Tokyo Woman's Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Incidence and severity of sleepiness (JESS score)

Secondary

MeasureTime frame
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

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026