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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Olopatadine 0.6% 1 Spray

Olopatadine HCl 0.6% 1 spray per nostril twice daily

Group Type EXPERIMENTAL

Olopatadine Hydrochloride Nasal Spray 0.6%

Intervention Type DRUG

Olopatadine HCl 1 or 2 sprays per nostril twice daily

Vehicle 1 spray

Vehicle 1 spray per nostril twice daily

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Vehicle 1 or 2 sprays per nostril twice daily

Olopatadine 0.6% 2 sprays

Olopatadine HCl 0.6% 2 sprays per nostril twice daily

Group Type EXPERIMENTAL

Olopatadine Hydrochloride Nasal Spray 0.6%

Intervention Type DRUG

Olopatadine HCl 1 or 2 sprays per nostril twice daily

Vehicle 2 sprays

Vehicle 2 sprays per nostril twice daily

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Vehicle 1 or 2 sprays per nostril twice daily

Interventions

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Olopatadine Hydrochloride Nasal Spray 0.6%

Olopatadine HCl 1 or 2 sprays per nostril twice daily

Intervention Type DRUG

Vehicle

Vehicle 1 or 2 sprays per nostril twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female; minimum of 6 years of age and less than 12 years
* 2 year history of seasonal allergic rhinitis

Exclusion Criteria

* Concurrent disease that might interfere with the investigation or evaluation of te study medication
* Confirmed diagnosis of chronic rhinosinusitis within the last year
* Asthma, with the exception of mild intermittent asthma
* Anatomical nasal deformity
* Nasal obstruction
* Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR)
* Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids
* Ocular disorder other that allergic conjunctivitis

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No