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Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

NCT01630135 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2017-01-11

Study results available
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Summary

Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to \< 15 years with perennial allergic rhinitis will be evaluated compared with placebo.

Conditions

  • Rhinitis, Allergic, Perennial

Interventions

DRUG

Fluticasone furoate

55 mcg/day, intranasal, 2 weeks

DRUG

Placebo

Placebo, intranasal, 2 weeks

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Japan

Study Locations

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Entities

Drugs
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 NCT01630135 on ClinicalTrials.gov