Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244230
• Other study ID #: SFY10718
• Secondary ID: U1111-1115-4048
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 15, 2010
• Last updated: October 12, 2013
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 11 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• fexofenadine/Allegra (M016455)
Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral

Locations

Country	Name	City	State
Japan	Investigational Site Number 392012	Hitachinaka-Shi
Japan	Investigational Site Number 392001	Isumi-Shi
Japan	Investigational Site Number 392010	Itoshima-Shi
Japan	Investigational Site Number 392002	Katsushika-Ku
Japan	Investigational Site Number 392006	Kofu-Shi
Japan	Investigational Site Number 392011	Komae-Shi
Japan	Investigational Site Number 392007	Komatsu-Shi
Japan	Investigational Site Number 392003	Koto-Ku
Japan	Investigational Site Number 392013	Nagano-Shi
Japan	Investigational Site Number 392009	Okayama-Shi
Japan	Investigational Site Number 392008	Osaka-Shi
Japan	Investigational Site Number 392004	Setagaya-Ku
Japan	Investigational Site Number 392005	Setagaya-Ku

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events		4 weeks	Yes
Primary	The number of clinically significant abnormalities for laboratory findings		4 weeks	Yes
Secondary	Number of patients with adverse events		12 weeks	Yes
Secondary	The number of clinically significant abnormalities for laboratory findings		12 weeks	Yes
Secondary	Changes from baseline in main itching scores on patient diary		4 weeks	No
Secondary	Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator		week 2 and 4	No
Secondary	Pharmacokinetic parameters of fexofenadine at steady state; AUC		week 4 and 12	No