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| Sponsored by: |
Sanofi-Aventis |
|---|---|
| Information provided by: | 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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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) |
| Estimated Enrollment: | 408 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
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
|
|
2: Placebo Comparator
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
|
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| Contact: Public Registry USMA | PublicRegistryUSMA@sanofi-aventis.com |
| United States, New Jersey | |
| Sanofi-aventis | Recruiting |
| Bridgewater, New Jersey, United States, 08807 | |
| Study Director: | Tara Semanchik, MBA | Sanofi-Aventis |
More Information
| Responsible Party: | sanofi-aventis ( Study Director ) |
| Study ID Numbers: | XRG5029C_3503 |
| Study First Received: | March 15, 2007 |
| Last Updated: | June 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00449072 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Rhinitis Triamcinolone diacetate Immunosuppressive Agents Hormones Glucocorticoids |
Triamcinolone hexacetonide Hypersensitivity Triamcinolone Acetonide Rhinitis, Allergic, Perennial Respiratory Tract Diseases Respiratory Tract Infections Triamcinolone Hypersensitivity, Immediate Respiratory Hypersensitivity |
|
Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Rhinitis Hormones Triamcinolone hexacetonide Hypersensitivity Triamcinolone Acetonide Respiratory Tract Infections Respiratory Tract Diseases Rhinitis, Allergic, Perennial |
Therapeutic Uses Triamcinolone Otorhinolaryngologic Diseases Immune System Diseases Triamcinolone diacetate Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents Nose Diseases Pharmacologic Actions Hypersensitivity, Immediate Respiratory Hypersensitivity |