|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by (Responsible Party): | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00449072 |
Purpose
The primary objective of the study is to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with PAR treated with TAA nasal spray (NASACORT AQ 110 μg treatment group) or placebo (NASACORT AQ placebo group) for 12-months.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis, Allergic, Perennial |
Drug: triamcinolone acetonide Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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) |
| Enrollment: | 299 |
| Study Start Date: | June 2006 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
triamcinolone acetonide (TAA) AQ 110 μg (one 55-μg actuation/nostril) administered intranasally qd in subjects 3 to 9 years of age
|
Drug: triamcinolone acetonide
triamcinolone acetonide (TAA) AQ 110 μg (one 55-μg actuation/nostril) administered intranasally qd in subjects 3 to 9 years of age
|
|
Placebo Comparator: 2
TAA AQ placebo (one actuation/nostril) administered intranasally qd in subjects 3 to 9 years of age
|
Other: placebo
TAA AQ placebo (one actuation/nostril) administered intranasally qd in subjects 3 to 9 years of age
Other Name: Nasacort AQ
|
Eligibility| Ages Eligible for Study: | 3 Years to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Study Director: | Tara Semanchik, MBA | Sanofi-Aventis |
More Information
| Responsible Party: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00449072 History of Changes |
| Other Study ID Numbers: | XRG5029C_3503 |
| Study First Received: | March 15, 2007 |
| Last Updated: | October 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Rhinitis Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Triamcinolone hexacetonide Triamcinolone Acetonide Triamcinolone |
Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |