NCT00700661

Brief Summary

A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Jan 2001

Typical duration for phase_3 asthma

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

January 1, 2001

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

June 17, 2008

Last Update Submit

August 12, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • asthma episodes in 2 - 5 year old children

    at 12 months

Secondary Outcomes (1)

  • the number of treatments and duration of asthma episodes

    at 12 months

Study Arms (2)

1

EXPERIMENTAL

Drug

Drug: montelukast

2

PLACEBO COMPARATOR

Pbo

Drug: placebo (unspecified)

Interventions

montelukastDRUG

One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks

Also known as: MK0476, SINGULAIR ®
1
placebo (unspecified)DRUG

Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks

2

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or Female between and including the ages of 2 and 5 years
  • Patient was treated with steroids for an asthma episode in the last 3 months
  • Patient was admitted to the hospital or emergency room in the last 3 months
  • Patient is able to chew a tablet

You may not qualify if:

  • Patient has been in a research study in the past 4 weeks
  • Patient has visited the emergency room for an asthma episode in the past week
  • Patients has a history of stomach, heart, liver, nerve, kidney or blood disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. doi: 10.1164/rccm.200407-894OC. Epub 2004 Nov 12.

    PMID: 15542792BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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

June 17, 2008

First Posted

June 19, 2008

Study Start

January 1, 2001

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

August 15, 2024

Record last verified: 2022-02