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NCT00449072 · ClinicalTrials.gov registry record · Phase 4

Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)

A Phase 4 study, sponsored by Sanofi.

Completed
Registry status
Phase 4
Development phase
299
Enrollment target

NCT00449072: Completed Phase 4 study, sponsored by Sanofi.

NCT00449072 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 299 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00449072, a Phase 4 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 4
Development phase
299 participants
Enrollment target

Study 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 cortisol/creatinine 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

Primary Outcome

Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time. Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing.

Interventions

  • OTHER Placebo
  • DRUG TAA-AQ, Nasacort® AQ
  • DRUG Claritin®

Trial Details

FieldValue
Enrollment Target 299 participants
Start Date 2007-03
Est. Completion 2011-10
Phase Phase 4
Sanofi

713 total trials

What the finished NCT00449072 record still lists

NCT00449072 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00449072 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00449072 about?

NCT00449072 is a clinical study titled "Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)". 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 g...

What is the current status of trial NCT00449072?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 299 participants. The study started on 2007-03. Estimated completion is 2011-10.

What interventions are being tested in trial NCT00449072?

The interventions under investigation include: Placebo (OTHER), TAA-AQ, Nasacort® AQ (DRUG), Claritin® (DRUG).

Who is sponsoring clinical trial NCT00449072?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00449072's enrollment target sits among peer trials

299 292nd of 2000 higher than 1,709 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00449072, the US trial registry maintained by the National Library of Medicine. NCT00449072 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.