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

Phase 3

• Conditions: Patients with perennial or seasonal allergic rhinitis.

• Registration Number: JPRN-jRCT2080222571
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 120

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

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.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidences of adverse events and adverse drug reactions<br>Systolic and diastolic pressure, Pulse, Temperature, Clinical lab, Physical examination, 12-lead ECG

Secondary Outcome Measures

Name	Time	Method
Mean change in total symptom scores <br>-TNSS; scores for rhinorrhea, sneezing, nasal congestion and nasal itching<br>-TSS; scores for rhinorrhea, sneezing, nasal congestion and nasal itching, eye itching and eye tearing<br>-T3NSS; scores for rhinorrhea, sneezing and nasal itching<br>-TOSS; scores for eye itching and eye tearing<br>To evaluete the symptoms score by subjects using the patient's diary card.<br>QOL<br>Japanese rhinoconjunctivitis quality of life questionnaire No 1<br>To evaluete the QOL score by patients using the QOL questionnaire<br>Degree of satisfaction with treatment<br>To evaluate the degree of patient's satisfaction with treatment<br>Degree of improvement<br>To evaluete the degree of improvement using the symptom score of the patient's diary card