PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)

Organon

Status and phase: Completed; Phase 2

Conditions: Bronchiolitis

Treatments: Drug: MK-0476, montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394069

0476-268

2006_545

Details and patient eligibility

About

The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 3 to 6 months of age with bronchiolitis.

Enrollment: 14 patients

Sex: All

Ages: 3 to 6 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms

Exclusion Criteria :

• A history of any significant illness that will pose additional risk to the patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 1 patient group

Montelukast sodium

Experimental group

Description:

Participants receive montelukast sodium for 14 days.

Treatment:

Drug: MK-0476, montelukast sodium