Chronic urticaria
Conditions
Interventions
Placebo or TK-042 administered orally as 1 tablet once daily for 1 week
Sponsors
Nishiyama Kenichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - >= 7 to < 12 years of age. - Chronic urticaria for over 6 weeks
Exclusion criteria
Exclusion criteria: - With the primary diagnosis of stimulus-inducible urticaria (e.g. physical urticaria [cold , solar or heat, etc.], cholinergic urticaria, and contact urticaria). - Have concominant skin disorders which Principal/sub-investigator judges to afffect the efficacy evaluation. - With uncontrolled mild to moderate bronchial asthma (those who require injectable, oral, or inhaled steroid medications), or with severe bronchial asthma. - Have history of hypersensitivity to antihistamine drugs or any ingredients of investigational drugs. - Currently undergoing allergen immunotherapy such as sublingual immunotherapy or have undergone such therapy within the past 3 years prior to screening. - Have severe hepatobiliary disorders. - Have severe renal or urinary disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in UAS7(Urticaria Actively Score 7) | — |
Contacts
Public ContactClinical Development Department
Teikoku Seiyaku Co., Ltd.
Outcome results
None listed