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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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