A phase III study of TAC-202 in patients with perennial allergic rhinitis

A double-blind, placebo-control, randomized phase III study to evaluate the efficacy and safety of TAC-202 in patients with perennial allergic rhinitis

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222549

Enrollment

750

Registered

2014-07-01

Start date

2014-07-01

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

Patients with perennial allergic rhinitis

Interventions

investigational material(s) Generic name etc : TAC-202 INN of investigational material : Bilastine Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who have been diagnosed with perennial allergic rhinitis and who have had related symptoms for 2 years or longer. Subjects who showed positive in nasal provocation test with house dust disc.

Exclusion criteria

Exclusion criteria: Subjects who previously developed anaphylaxis to antihistamine drugs, fexofenadine or ingredients of the investigational drug. Subjects with any of the following complications that may hinder efficacy evaluation - Vasomotor rhinitis, - Eosinophilic rhinitis, - Drug-induced rhinitis, - Viral conjunctivitis, - Otitis media, - Others (acute/chronic rhinitis, hypertrophic rhinitis, sinusitis, nasal polyps, repetitive nasal hemorrhage, treatment-requiring nasal septal deviation, etc.)

Design outcomes

Secondary

Measure	Time frame
QOL Japanese rhinoconjunctivitis quality of life questionnaire No 1 To evaluete the QOL score by patients using the QOL questionnaire Degree of satisfaction with treatment To evaluate the degree of patient's satisfaction with treatment Degree of improvement To evaluete the degree of improvement using the symptom score of the patient's diary card Incidences of adverse events and adverse drug reactions Systolic and diastolic pressure, Pulse, Temperature, Clinical lab, Physical examination, 12-lead ECG	—

Measure

Time frame

QOL Japanese rhinoconjunctivitis quality of life questionnaire No 1 To evaluete the QOL score by patients using the QOL questionnaire Degree of satisfaction with treatment To evaluate the degree of patient's satisfaction with treatment Degree of improvement To evaluete the degree of improvement using the symptom score of the patient's diary card Incidences of adverse events and adverse drug reactions Systolic and diastolic pressure, Pulse, Temperature, Clinical lab, Physical examination, 12-lead ECG

—

Primary

Measure	Time frame
Mean change in total nasal symptom scores (TNSS; scores for rhinorrhea, sneezing, nasal congestion and nasal itching) To evaluete the symptoms score by subjects using the patient's diary card.	—

Outcome results

None listed

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