CompletedPhase 2

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

12 participantsStarted 2004-12

Plain-language summary

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.

Who can participate

Age range1 Month – 3 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.

Trial details

NCT IDNCT00394160

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-10

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