NCT00968201

Brief Summary

A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
689

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Dec 1997

Longer than P75 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

December 1, 1997

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
8.5 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
11 months until next milestone

Results Posted

Study results publicly available

August 3, 2010

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

August 27, 2009

Results QC Date

September 15, 2009

Last Update Submit

February 1, 2022

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study

    An 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

    12 weeks of treatment

Secondary Outcomes (26)

  • Number of Patients With Drug-related CAEs Reported by Patients - Base Study

    12 weeks of treatment

  • Number of Patients With Serious CAEs Reported by Patients - Base Study

    12 weeks of treatment

  • Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study

    12 weeks of treatment

  • Number of Patients Who Were Discontinued Due to CAEs - Base Study

    12 weeks of treatment

  • Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study

    12 weeks of treatment

  • +21 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Montelukast

Drug: montelukast sodium

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

montelukast sodiumDRUG

one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks

1
Comparator: PlaceboDRUG

one chewable placebo tablet, once daily at bedtime for 12 weeks

2

Eligibility Criteria

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

You may qualify if:

  • Patient has history of physician diagnosed asthma
  • Patient is in otherwise good stable health
  • Patient is able to chew a tablet

You may not qualify if:

  • Patient is hospitalized
  • Patient and/or parent of guardian intends to move or vacation away from home during the course of the study
  • Patient had any major surgical procedure within 4 weeks before the study
  • Patient had active sinus disease within 3 weeks before the study
  • Patient had required intubation for asthma in the past
  • Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study
  • Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Knorr B, Franchi LM, Bisgaard H, Vermeulen JH, LeSouef P, Santanello N, Michele TM, Reiss TF, Nguyen HH, Bratton DL. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics. 2001 Sep;108(3):E48. doi: 10.1542/peds.108.3.e48.

    PMID: 11533366RESULT

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

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

December 1, 1997

Primary Completion

March 1, 2001

Study Completion

March 1, 2001

Last Updated

February 3, 2022

Results First Posted

August 3, 2010

Record last verified: 2022-02