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Completed

NCT Number: NCT00968149

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

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

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

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

Comparator: placebo

Drug

one placebo chewable tablet daily at bed time for 2 weeks

Primary outcomes

  1. Number of Patients With Clinical Adverse Experiences (CAEs)

    Time frame: 2 weeks

    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

Secondary outcomes

  1. Number of Patients With Serious CAEs

    Time frame: 2 weeks

    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. Number of Patients With Drug-related CAEs

    Time frame: 2 weeks

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

  3. Number of Patients Who Were Discontinued Due to CAEs

    Time frame: 2 weeks

  4. Number of Patients With Laboratory Adverse Experiences (LAEs)

    Time frame: 2 weeks

    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

  5. Number of Patients With Serious LAEs

    Time frame: 2 weeks

    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

  6. Number of Patients With Drug-related LAEs

    Time frame: 2 weeks

  7. Number of Patients Who Were Discontinued Due to LAEs

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Aug 28, 2009
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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