Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)

Organon

Status and phase: Completed; Phase 2

Conditions: Bronchiolitis

Treatments: Drug: MK0476, Montelukast Sodium /Duration of Treatment : 14 Days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394160

0476-297

2006_544

Details and patient eligibility

About

The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to < 3 months of age with bronchiolitis.

Enrollment: 12 patients

Sex: All

Ages: 1 to 3 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

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

Exclusion Criteria :

• Anemia or 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