Phase III Clinical Trial of TO-194SL - Efficacy and Safety Evaluation in Patients with Japanese Cedar Pollinosis
- Conditions
- Japanese cedar pollinosis
- Registration Number
- JPRN-jRCT2080221222
- Lead Sponsor
- TORII PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 440
1)Patients with specific IgE against cedar pollen CAP class 3 or more
2)Patients with clinical history of cedar pollinosis in cedar pollen dispersion season
1)Patients with complication of nose disease that may interfere with evaluation (nasal polyps, deviation of nasal septum), chronic sinusitis, etc
2)Patients who have developed asthmatic attack within 5 years before the pre-treatment observation visit
3)Patients who have received specific immunotherapy for cedar pollinosis in history
4)Patients with during pregnancy, breast-feeding, possibility of pregnancy or wish to pregnancy during this clinical study period
5)Patients who have participated in any other clinical study or clinical research (including medical equipment study) within 12 weeks before the pre-treatment observation visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total nasal symptom medication score
- Secondary Outcome Measures
Name Time Method