Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449072
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2007-03-15
Brief Title:
Study of Triamcinolone Acetonide on the Growth Velocity of Children Ages 3 to 9 With Perennial Allergic Rhinitis PAR
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Multicenter Double-blind Placebo-controlled Parallel Group Study of the 12 Month Effect of Treatment With Once Daily Triamcinolone Acetonide NASACORT AQ Nasal Spray 110 μg on the Growth Velocity of Children 3 to 9 Years of Age With Perennial Allergic Rhinitis PAR
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study was to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with perennial allergic rhinitis PAR treated with triamcinolone acetonide TAA nasal spray NASACORT AQ 110 μg treatment group or placebo NASACORT AQ placebo group for 12-months
The secondary objectives were to compare the following in prepubertal participants treated with TAA nasal spray versus placebo
the 24-hour urinary free cortisol levels and the cortisolcreatinine ratio to measure the Hypothalamic-Pituitary Adrenal HPA axis function
the rate of treatment-emergent-adverse-events TEAE
global efficacy rated by the investigator and the participant separately
the rate of use of rescue medication during the study
The secondary objectives were to compare the following in prepubertal participants treated with TAA nasal spray versus placebo
the 24-hour urinary free cortisol levels and the cortisolcreatinine ratio to measure the Hypothalamic-Pituitary Adrenal HPA axis function
the rate of treatment-emergent-adverse-events TEAE
global efficacy rated by the investigator and the participant separately
the rate of use of rescue medication during the study
Detailed Description:
The study consisted of
a 4- to 6-month screeningbaseline period
a 12-month up to Day 360-5 days double-blind treatment period starting on Day 1
a 2-month follow-up period up to Day 420-5 days
a 4- to 6-month screeningbaseline period
a 12-month up to Day 360-5 days double-blind treatment period starting on Day 1
a 2-month follow-up period up to Day 420-5 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None