Patients with perennial or seasonal allergic rhinitis.
Conditions
Sponsors
Taiho Pharmaceutical Co., Ltd.
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 have been diagnosed with seasonal allergic rhinitis and who have had related symptoms in Japanese ceder and Japanese cypress pollen season for 2 years or longer.
Exclusion criteria
Exclusion criteria: Subjects who previously developed anaphylaxis to antihistamine drugs, 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 or chronic rhinitis, hypertrophic rhinitis, sinusitis, nasal polyps, repetitive nasal hemorrhage, treatment-requiring nasal septal deviation, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of adverse events and adverse drug reactions Systolic and diastolic pressure, Pulse, Temperature, Clinical lab, Physical examination, 12-lead ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in total symptom scores -TNSS; scores for rhinorrhea, sneezing, nasal congestion and nasal itching -TSS; scores for rhinorrhea, sneezing, nasal congestion and nasal itching, eye itching and eye tearing -T3NSS; scores for rhinorrhea, sneezing and nasal itching -TOSS; scores for eye itching and eye tearing To evaluete the symptoms score by subjects using the patient's diary card. 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 | — |
Outcome results
None listed