A phase III study of TAC-202 in patients with perennial allergic rhinitis
Phase 3
- Conditions
- Patients with perennial allergic rhinitis
- Registration Number
- JPRN-jRCT2080222549
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 750
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
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.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in total nasal symptom scores (TNSS; scores for rhinorrhea, sneezing, nasal congestion and nasal itching)<br>To evaluete the symptoms score by subjects using the patient's diary card.
- Secondary Outcome Measures
Name Time Method 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<br>Incidences of adverse events and adverse drug reactions<br>Systolic and diastolic pressure, Pulse, Temperature, Clinical lab, Physical examination, 12-lead ECG