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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1115-4048 | Other Identifier | UTN |
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Primary Objective:
To evaluate safety (4 weeks)
Secondary Objectives:
The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age 6 months - 2 years | Experimental | Patients between 6 months and 2 years old - Type: Experimental |
|
| Age 2 - 11 years | Experimental | Patients between 2 and 11 years (and under 10.5 kg) |
|
| Age 2 - 11 years (and over 10.5 kg) | Experimental | Patients between 2 and 11 years (and over 10.5 kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fexofenadine/Allegra (M016455) | Drug | Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | 4 weeks | |
| The number of clinically significant abnormalities for laboratory findings | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | 12 weeks | |
| The number of clinically significant abnormalities for laboratory findings | 12 weeks | |
| Changes from baseline in main itching scores on patient diary |
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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 392012 | Hitachi-Naka | Japan | ||||
| Investigational Site Number 392001 |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C093230 | fexofenadine |
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| 4 weeks |
| Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator | week 2 and 4 |
| Pharmacokinetic parameters of fexofenadine at steady state; AUC | week 4 and 12 |
| Isumi |
| Japan |
| Investigational Site Number 392010 | Itoshima-Shi | Japan |
| Investigational Site Number 392002 | Katsushika-ku | Japan |
| Investigational Site Number 392006 | Kofu | Japan |
| Investigational Site Number 392011 | Komae-Shi | Japan |
| Investigational Site Number 392007 | Komatsu-Shi | Japan |
| Investigational Site Number 392003 | KÅtoku | Japan |
| Investigational Site Number 392013 | Nagano | Japan |
| Investigational Site Number 392009 | Okayama | Japan |
| Investigational Site Number 392008 | Osaka | Japan |
| Investigational Site Number 392004 | Setagaya-Ku | Japan |
| Investigational Site Number 392005 | Setagaya-Ku | Japan |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |