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

NCT ID: NCT00968149

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2001-07-31

Brief Summary

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

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Montelukast

Group Type: EXPERIMENTAL

montelukast sodium

Intervention Type: DRUG

one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years

2

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

one placebo chewable tablet daily at bed time for 2 weeks

Interventions

montelukast sodium

one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years

Intervention Type: DRUG

Comparator: Placebo

one placebo chewable tablet daily at bed time for 2 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, Knorr B, Noonan G. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009 Jun;44(6):568-79. doi: 10.1002/ppul.21018.

Reference Type: RESULT

PMID: 19449366 (View on PubMed)

Other Identifiers

MK0476-219

Identifier Type: -

Identifier Source: secondary_id

2009_652

Identifier Type: -

Identifier Source: secondary_id

0476-219

Identifier Type: -

Identifier Source: org_study_id