Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01244230
First received: November 15, 2010
Last updated: September 13, 2011
Last verified: September 2011
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Purpose
Primary Objective:
To evaluate safety (4 weeks)
Secondary Objectives:
- To evaluate the long-term safety (12 weeks)
- To evaluate the efficacy
- To characterize the pharmacokinetic profile
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Drug: fexofenadine/Allegra (M016455) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Uncontrolled 4-week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Atopic Dermatitis |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Number of patients with adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- The number of clinically significant abnormalities for laboratory findings [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of patients with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- The number of clinically significant abnormalities for laboratory findings [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Changes from baseline in main itching scores on patient diary [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator [ Time Frame: week 2 and 4 ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters of fexofenadine at steady state; AUC [ Time Frame: week 4 and 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2010 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Age 6 months - 2 years
Patients between 6 months and 2 years old - Type: Experimental
|
Drug: fexofenadine/Allegra (M016455)
Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral |
|
Experimental: Age 2 - 11 years
Patients between 2 and 11 years (and under 10.5 kg)
|
Drug: fexofenadine/Allegra (M016455)
Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral |
|
Experimental: Age 2 - 11 years (and over 10.5 kg)
Patients between 2 and 11 years (and over 10.5 kg)
|
Drug: fexofenadine/Allegra (M016455)
Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 6 Months to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Aged 6 months through 11 years
- Patients with atopic dermatitis
Exclusion criteria:
- Main itching scores are 4 or less than 2 on last three consecutive days before registration.
- Patients who have itching only on face, head, or diaper area.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244230
Locations
| Japan | |
| Investigational Site Number 392012 | |
| Hitachinaka-Shi, Japan, 312-0057 | |
| Investigational Site Number 392001 | |
| Isumi-Shi, Japan, 299-4503 | |
| Investigational Site Number 392010 | |
| Itoshima-Shi, Japan, 819-1108 | |
| Investigational Site Number 392002 | |
| Katsushika-Ku, Japan, 125-0042 | |
| Investigational Site Number 392006 | |
| Kofu-Shi, Japan, 400-0026 | |
| Investigational Site Number 392011 | |
| Komae-Shi, Japan, 201-8601 | |
| Investigational Site Number 392007 | |
| Komatsu-Shi, Japan, 923-8560 | |
| Investigational Site Number 392003 | |
| Koto-Ku, Japan, 136-0074 | |
| Investigational Site Number 392013 | |
| Nagano-Shi, Japan, 381-0025 | |
| Investigational Site Number 392009 | |
| Okayama-Shi, Japan, 701-0205 | |
| Investigational Site Number 392008 | |
| Osaka-Shi, Japan | |
| Investigational Site Number 392004 | |
| Setagaya-Ku, Japan, 157-0066 | |
| Investigational Site Number 392005 | |
| Setagaya-Ku, Japan, 158-0097 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01244230 History of Changes |
| Other Study ID Numbers: | SFY10718, U1111-1115-4048 |
| Study First Received: | November 15, 2010 |
| Last Updated: | September 13, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fexofenadine |
Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013