A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)

Organon

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: montelukast sodium; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00968149

MK0476-219

2009_652

0476-219

Details and patient eligibility

About

This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.

Enrollment: 413 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a history of allergic rhinitis symptoms which flare up during the study season
• Patient is a non-smoker
• Patient is in otherwise good health
• Patient is able to chew a tablet

Exclusion criteria

• Patient is hospitalized
• Patient is pregnant or nursing mother, or <8 weeks post partum
• Patient and/or parent intend to move or vacation away from home during the trial
• Patient has had a major surgical procedure within 4 weeks of the prestudy visit
• Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study
• Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study
• Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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413 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Montelukast

Treatment:

Drug: montelukast sodium

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo