Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

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Organon

Status and phase

Completed
Phase 3

Conditions

Asthma

Treatments

Drug: Comparator: Placebo
Drug: montelukast sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00968201
0476-072
2009_651

Details and patient eligibility

About

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

Enrollment

689 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

689 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Montelukast
Treatment:
Drug: montelukast sodium
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Comparator: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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