perennial allergic rhinitis
Conditions
Interventions
Placebo administered orally as 1 tablet once daily for 1 week, TK-042 administered orally as 1 tablet once daily for 12 weeks.
Sponsors
Nishiyama Kenichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - >= 7 to = 2) specific IgE antibodies test (e.g., CAP-RAST, AlaSTAT 3g, etc.) for antigens of perennial allergic rhinitis.
Exclusion criteria
Exclusion criteria: - Have concomitant nasal disorders (e.g., nasal polyps, nasal septum deviation, hypertrophic rhinitis, etc.) or infectious diseases (e.g., upper respiratory tract inflammation, sinusitis, infectious rhinitis, eye infections, etc.) to a degree that would interfere with the efficacy evaluation. - Have non-allergic rhinitis (e.g., vasomotor, infectious, drug-induced, etc.) or history of non-allergic rhinitis. - Have undergone coagulation (e.g., laser) or ablative surgery for the treatment of nasal symptoms within 1 year prior to obtaining consent. - Have uncontrolled mild and moderate bronchial asthma (patients with conditions that require the use of injectable, oral, or inhaled steroid preparations), or severe bronchial asthma. - Have a history of hypersensitivity to antihistamines, including this drug, or any ingredient of investigational drugs. - Have severe hepatobiliary disorders. - Have severe renal or urinary disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints (laboratory tests, vital signs, adverse events) | — |
Contacts
Public ContactClinical Development Department
Teikoku Seiyaku Co., Ltd.
Outcome results
None listed