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Phase IV clinical trial of TO-194SL -Evaluation of long-term efficacy and safety in patients with Japanese cedar pollinosis -

Phase IV clinical trial of TO-194SL -Evaluation of long-term efficacy and safety in patients with Japanese cedar pollinosis -

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080222534
Enrollment
230
Registered
2014-06-18
Start date
2014-07-07
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

Japanese cedar pollinosis

Interventions

investigational material(s) Generic name etc : TO-194SL INN of investigational material : - Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational mate

Sponsors

Torii Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with specific IgE against cedar pollen : class 3 or more. 2)Patients who have a clinical history of cedar pollinosis in 2013 and 2014 cedar pollen seasons.

Exclusion criteria

Exclusion criteria: 1)Patients with perennial allergic rhinitis, medication-derived rhinitis, vasomotor rhinitis or non-allergic rhinitis during therapy. 2)Patients who have developed asthmatic attack within 5 years before the pre-treatment observation visit. 3)Patients who have received specific immunotherapy for cedar pollinosis in history.

Design outcomes

Primary

MeasureTime frame
efficacy Total nasal symptom medication score (TNSMS) during symptom peak period.

Secondary

MeasureTime frame
efficacy Total nasal ocular symptom medication score (TNOSMS) during symptom peak period. safety Adverse Events (AEs) and Adverse Drug Reactions (ADRs)

Countries

Japan

Outcome results

None listed

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