A Double-blind, Parallel-group Phase III Study of TK-041 in Patients with Chronic Urticaria

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222734

Enrollment

270

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

Chronic urticaria

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: Chronic urticaria for over a month

Exclusion criteria

Exclusion criteria: Other skin diseases which interfere with the evaluation Hypersensitivity to antihistamine drugs or study drug

Design outcomes

Primary

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

Secondary

Measure	Time frame
DLQI Using the QOL questionnaire by patients Adverse events Clinical examination	—

Outcome results

None listed

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