NCT00968149

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
413

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2001

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
4 months until next milestone

Results Posted

Study results publicly available

December 11, 2009

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

August 27, 2009

Results QC Date

September 15, 2009

Last Update Submit

February 1, 2022

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Number of Patients With Serious CAEs

    2 weeks

  • Number of Patients With Drug-related CAEs

    2 weeks

  • Number of Patients Who Were Discontinued Due to CAEs

    2 weeks

  • Number of Patients With Laboratory Adverse Experiences (LAEs)

    2 weeks

  • Number of Patients With Serious LAEs

    2 weeks

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Montelukast

Drug: montelukast sodium

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

montelukast sodiumDRUG

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

1
Comparator: PlaceboDRUG

one placebo chewable tablet daily at bed time for 2 weeks

2

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.21018.

    PMID: 19449366RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

montelukast

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Limitations and Caveats

Efficacy endpoints are exploratory.

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2009

First Posted

August 28, 2009

Study Start

March 1, 2001

Primary Completion

June 1, 2001

Study Completion

July 1, 2001

Last Updated

February 3, 2022

Results First Posted

December 11, 2009

Record last verified: 2022-02