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Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.

NCT00570492 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2017-09-15

Study results available
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Summary

The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.

Conditions

  • Rhinitis, Allergic, Perennial

Interventions

DRUG

Fluticasone furoate nasal spray

Fluticasone furoate nasal spray 110mg QD

DRUG

Placebo nasal spray

Placebo nasal spray

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-26
Primary Completion
2011-03-01
Completion
2011-03-17

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • France
  • Italy
  • Peru

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00570492 on ClinicalTrials.gov