Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00305487
First received: March 21, 2006
Last updated: May 4, 2012
Last verified: June 2011

March 21, 2006
May 4, 2012
March 2006
October 2006   (final data collection date for primary outcome measure)
Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment
Average of morning and evening parent/caregiver reported reflective Total Nasal Symptoms Score over the two weeks of treatment.
Complete list of historical versions of study NCT00305487 on ClinicalTrials.gov Archive Site
  • Physician assessment of nasal symptoms score at endpoint
  • average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment
  • safety
  • Physician assessment of Nasal Symptoms Score at endpoint
  • average of morning and evening parent/caregiver reported instantaneous Total Nasal Symptom Score over the two weeks of treatment
  • safety.
Not Provided
Not Provided
 
Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
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

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Hay Fever
  • Seasonal Allergic Rhinitis
Drug: Ciclesonide nasal spray
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
October 2006
October 2006   (final data collection date for primary outcome measure)

Main Inclusion Criteria:

  • Written informed consent
  • General good health other than seasonal allergic rhinitis
  • Positive standard skin prick test

Main Exclusion Criteria:

  • Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit
  • A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
  • Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
  • Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
  • Use of any prohibited concomitant medications
  • Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
  • Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
  • Study participation by more than one patient from the same household
Both
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00305487
BY9010/M1-417
Not Provided
Nycomed, Clinical Trial Operations
Takeda
Not Provided
Study Chair: Mark A. Wingertzahn, PhD ALTANA Pharma, Florham Park, NJ 07932, USA, info.clintrials@altanapharma.com
Takeda
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP