Phase 3 N=413 Randomized Double-blind Treatment

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

Seasonal Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT00968149 ↗

Enrolled (actual)

413

Serious AEs

0.2%

Results posted

Dec 2009

Primary outcome: Primary: Number of Patients With Clinical Adverse Experiences (CAEs) — 73; 35; 207; 98 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: montelukast sodium (Drug); Comparator: Placebo (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Jun 2001

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Clinical Adverse Experiences (CAEs)	73; 35; 207; 98	—
SECONDARY Number of Patients With Serious CAEs	1; 0; 279; 133	—
SECONDARY Number of Patients With Drug-related CAEs	10; 5; 270; 128	—
SECONDARY Number of Patients Who Were Discontinued Due to CAEs	5; 1; 275; 132	—
SECONDARY Number of Patients With Laboratory Adverse Experiences (LAEs)	2; 3; 270; 126	—
SECONDARY Number of Patients With Serious LAEs	0; 0; 272; 129	—
SECONDARY Number of Patients With Drug-related LAEs	1; 2; 271; 127	—
SECONDARY Number of Patients Who Were Discontinued Due to LAEs	0; 0; 272; 129	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00968149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.