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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1152-0373 | Other Identifier | UTN |
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Primary Objective:
To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen exposure.
Secondary Objective:
To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar pollen exposure.
It will be 8 days at minimum and up to 17 days depending on screening visit and post-treatment observation allowances.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fexofenadine HCl | Experimental | 2 tablets of Dellegra Combination Tablets (Fexofenadine Hydrochloride 30 mg+Pseudoephedrine Hydrochloride 60 mg/tablet), oral, administrated 2 hours after start of exposure with 8,000 grains/cubic meter of Japanese cedar pollen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg | Drug | Pharmaceutical form:tablet Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Total Nasal Symptom Score (sneezing, nasal discharge, nasal congestion, and itchy nose | From 2 hours after antigen exposure (baseline) to 3 hours after intake of Dellegra |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of Total Symptom Score (sneezing, nasal discharge, nasal congestion, itchy nose, lacrimation, and eye itching | Prior to exposure, and every 15 minutes for 5 hours after exposure start | |
| Overall patients' impression about efficacy of Dellegra after Dellegra internal use (Score 1 [none] to 7 [very severe]) |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 392-001 | Shinjuku-ku | Japan |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093230 | fexofenadine |
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| From intake of Dellegra up to 17 days |
| Number of patients who experienced adverse events | From intake of Dellegra up to 17 days |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |