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Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

NCT00578929 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2388

Last updated 2010-03-02

Study results available
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Summary

A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Olopatadine Hydrochloride Nasal Spray 0.6%

Olopatadine HCl 1 or 2 sprays per nostril twice daily

DRUG

Vehicle

Vehicle 1 or 2 sprays per nostril twice daily

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-11-30

Countries

  • United States

Study Locations

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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 NCT00578929 on ClinicalTrials.gov