MedTrace Logo

Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

NCT00789555 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1260

Last updated 2018-02-08

Study results available
· View outcomes & findings →

Summary

The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

Olopatadine hydrochloride 0.6% nasal spray (PATANASE)

Two sprays in each nostril twice a day (morning and evening) for up to 12 months

OTHER

Olopatadine nasal spray vehicle, pH 3.7

Two sprays in each nostril twice a day (morning and evening) for up to 12 months

OTHER

Olopatadine nasal spray vehicle, pH 7.0

Two sprays in each nostril twice a day (morning and evening) for up to 12 months

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00789555 on ClinicalTrials.gov