JRCT ID: jRCT2080221241
Registered date:14/09/2010
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Seasonal Allergic Rhinitis |
Date of first enrollment | 14/09/2010 |
Target sample size | 48 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : Z-207 INN of investigational material : Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : Z-207 ( 0.6 mL, 1.0 mL, 2.0 mL ) , a single injection into the mucosa of both inferior turbinates control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo 2.0 mL, a single injection into the mucosa of both inferior turbinates |
Outcome(s)
Primary Outcome | Total nasal symptom score under exposure to allergen using pollen challenge chamber, and nasal symptom score natural exposure to allergen during the pollen season |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 64age old |
Gender | Both |
Include criteria | Patient with history of moderate to sever seasonal allergic rhinitis for at least 2 years Patient with positive reaction for Radio Allergen Sorbent Test using Japanease ceder pollen Patient exhibit both a total nasal symptom score of at least 4, and a nasal obstruction score of at least 2 under exposure to allergen using pollen challenge chamber ( Total nasal symptom score is the sum of sneezing, nasal discharge, nasal obstruction which has been scored on a scale from 0 to 4 ) |
Exclude criteria | Patient with positive reaction for Radio Allergen Sorbent Test for house dust mite Patient with positive reaction for Radio Allergen Sorbent Test for orchard grass pollen Patient who never received medical drug therapy for allergic rhinitis |
Related Information
Primary Sponsor | Zeria Pharmaceutical Co., Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-101278 |
Contact
Public contact | |
Name | |
Address | 03-5644-7053 |
Telephone | |
Affiliation | Zeria Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |