Recent Updates
Recently added Catalysts

Triamcinolone

Phase 3

Rhinitis, Allergic, Perennial | Small molecule | Respiratory |Sanofi|Last Updated: Jan 11, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment460

FDA Designations

No designations recorded

Clinical trial landscape

Triamcinolone · 1 trial · 1 indication

Phase 3 1
NCT00132925An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic RhinitisRhinitis, Allergic, Perennial
COMPLETED460 Analytics
PHASE3COMPLETED
An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis
Rhinitis, Allergic, Perennial
NCT00132925460
Unlock trial analytics

Study Endpoints

Primary Endpoints

Double-blind phase: Change from baseline in mean daily instantaneous (immediately prior to dosing) Total Nasal Symptom Score (TNSS) over the 4-week double-blind period
Open-label phase: The efficacy variable is the global evaluation of efficacy as rated by the physician and the subject

Secondary Endpoints

Change from baseline: in mean daily reflective (previous 24 hours) TNSS over 4-wk double-blind period
for mean daily instantaneous and reflective TNSS by week
for mean instantaneous and reflective daily scores for nasal stuffiness, nasal discharge, sneezing, nasal itching, and total eye symptoms by week and over four week double-blind period
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
TriamcinoloneDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range2 Years to 5 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects will be male or female children ages 2-5 years with a history of at least 1 year of perennial allergic rhinitis (PAR) with or without seasonal allergic rhinitis (SAR) characterized by nasal stuffiness, nasal discharge, sneezing, nasal itching, and total eye symptoms, ...

Countries:United States
Unlock Eligibility Criteria