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Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age

NCT00794144 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2010-03-04

Study results available
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Summary

The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children

Conditions

  • Allergic Rhinitis

Interventions

DRUG

Olopatadine Hydrochloride Nasal Spray 0.6%

one spray in each nostril twice daily for 2 weeks

DRUG

Olopatadine Hydrochloride Nasal Spray Vehicle

one spray in each nostril twice daily for 2 weeks

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Niran Amar, MD

  • Sheri Byrd, MD · Spartanburg Medical Center

  • Albert Finn, MD · National Allergy, Asthma, & Urticaria

  • Joseph Flanagan, MD · Health Sciences Research Center

  • Brad H Goodman, MD · Aeroallergy Research Laboratories

  • Frank Hampel, MD · Central Texas Allergy and Asthma

  • Yu-Luen Hsu, MD · West Coast Clinical Trials Phase 2-4

  • Neil Kao, MD · Allergic Disease and Asthma Cente

  • John Prestigiacomo, MD · Gulf Coast Research Associates, Inc

  • Paul Ratner, MD · Sylvana Research Associates

  • Christopher Smith, MD · Asthma and Allergy Associates, P.C.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-12-31

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 NCT00794144 on ClinicalTrials.gov