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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968149
• Other study ID #: 0476-219
• Secondary ID: MK0476-2192009_6
• Status: Completed
• Phase: Phase 3
• Start date: March 2001
• Est. completion date: July 2001

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: July 2001
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• 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
• Comparator: Placebo
one placebo chewable tablet daily at bed time for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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.210 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Clinical Adverse Experiences (CAEs)	A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product	2 weeks
Secondary	Number of Patients With Serious CAEs	Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	2 weeks
Secondary	Number of Patients With Drug-related CAEs	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs	2 weeks
Secondary	Number of Patients Who Were Discontinued Due to CAEs		2 weeks
Secondary	Number of Patients With Laboratory Adverse Experiences (LAEs)	A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product	2 weeks
Secondary	Number of Patients With Serious LAEs	Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	2 weeks
Secondary	Number of Patients With Drug-related LAEs		2 weeks
Secondary	Number of Patients Who Were Discontinued Due to LAEs		2 weeks