A Double-blind, Parallel-group Phase III Study of TK-041 in Patients with Seasonal Allergic Rhinitis

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222733

Enrollment

900

Registered

2015-01-30

Start date

2015-01-30

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

Seasonal allergic rhinitis

Interventions

investigational material(s) Generic name etc : TK-041 INN of investigational material : Rupatadine Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Symptoms of allergic rhinitis in cedar pollen season for 2 years or longer

Exclusion criteria

Exclusion criteria: Nose diseases (nasal polypus, nasal septum curvature symptom, hypertrophic rhinitis, etc.) or infectious diseases (upper respiratory tract inflammation, sinusitis, infectious rhinitis, infectious ophthalmopathy, etc.) that may interfere with the evaluation Hypersensitivity to antihistamine drugs or study drug

Design outcomes

Primary

Measure	Time frame
Change from baseline in total nose symptom score Using the patient's diary	—

Secondary

Measure	Time frame
Change from baseline in total eye symptom score Using the patient's diary JRQLQ Using the QOL questionnaire by patients Adverse events Clinical examination	—

Outcome results

None listed

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