Safety and Efficacy of Ciclesonide in Pediatric patients (6 to 11 years of age) with Seasonal Allergic Rhinitis (BY9010/M1-417)

Study identifier:BY9010/M1-417

ClinicalTrials.gov identifier:NCT00305487

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, once daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age

Medical condition

Hay Fever

Phase

Phase 3

Healthy volunteers

No

Study drug

Ciclesonide nasal spray

Sex

All

Actual Enrollment

660

Study type

Interventional

Age

6 Years - 11 Years

Date

Study Start Date: 01 Mar 2006
Primary Completion Date: 01 Oct 2006
Study Completion Date: 01 Oct 2006

Study design

Allocation: Randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria