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Phase III study of HP-3060

A randomized, double-blind, placebo-controlled, parallel group comparative study of HP-3060 in patients with seasonal allergic rhinitis

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223038
Enrollment
Unknown
Registered
2015-12-09
Start date
2015-12-09
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 : HP-3060 (Emedastine fumarate) INN of investigational material : emedastine Therapeutic category code : 449 Other antiallergic agents Dosage and Administr

Sponsors

Hisamitsu Pharmaceutical Co., Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients with a diagnosis of seasonal allergic rhinitis and symptoms of this condition for at least two years.

Exclusion criteria

Exclusion criteria: - Patients with rhinosinusitis or with any type of rhinitis other than allergic rhinitis, including vasomotor rhinitis and non-allergic rhinitis with eosinophilia. - Patients with polyps or polyp-like lesions that could influence assessment of nasal obstruction. - Patients with adenoid hypertrophy or nasal malformations (deviation of the nasal septum, hypertrophic rhinitis, or choanal atresia) that could influence assessment of nasal obstruction. - Patients receiving hyposensitization therapy or nonspecific immunotherapy who have not reached the maintenance stage. - Patients with a history of hypersensitivity to emedastine, levocetirizine, or piperazine derivatives.

Design outcomes

Primary

MeasureTime frame
Efficacy

Secondary

MeasureTime frame
Safety

Outcome results

None listed

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