None listed
Conditions
Interventions
Montelukast in oral granules in single daily doses of 4mg in children from 3 to 6 months of age in period I, in period II and III placebo.
Group name:Montelukast Type of group
Montelukast in oral granules in single daily doses of 4mg in children from 3 to 6 months of age in period I and II, in period III 8 mg montelukast.
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: a. The patient is a boy or girl of> 3 months to <6 months of age at the time of administration of the drug. b. The parent / legal guardian accepts the patient´s participation in the study as indicated by the signature of the parent / legal guardian in the consent form. The patient and the parent / guardian are willing to comply with the procedures and can make scheduled clinic visits. c. The good health of a patient (without taking into account his bronchiolitis) is determined based on medical history and physical examination. d. The patient is within the 5 ´° and 95´ ° percentile height by weight. e. The patient has received semi-solid foods, or soft foods for at least 1 week. F. The patient has received applesauce or products containing apple at least twice before the administration of the medication in Visit 2. g. The patient has active bronchiolitis or a history of bronchiolitis and asthma-like symptoms.
Exclusion criteria
Exclusion criteria: a. The person in charge of patient care (parent / guardian) is, in opinion of the researcher, mentally or legally disabled, so that it is not possible Obtain informed consent. j. The patient has used astemizole within 3 months prior to Visit 1 or terfenadine, and / or loratadine, within the 10 days prior to Visit 1. c. The patient has a history of any disease that, in the opinion of the researcher, could confuse the results of the study or pose a risk additional when administering montelukast to the patient. d. The patient has significant or unexplained abnormalities in the examination Pre-study physical and / or laboratory safety measurements (Appendices 4 and 5). and. The patient is in a situation (for example, is in the care of a surrogate family, unreliable, in moving) or have a medical problem which, in the opinion of the researcher, could interfere with their optimal participation in the study. F. The patient has a history of any disease clinically significant of the gastrointestinal, cardiovascular, hepatic systems, neurological, renal, genitourinary or hematologic or have a disease pulmonary that is not bronchiolitis or has symptoms similar to asthma. g. The patient has a history of a clinically serious adverse event meaningful in relation to the administration of a medication either commercial or research (for example, angioedema, anaphylaxis). h. The patient has undergone surgery or has participated in another clinical study within 8 weeks prior to Visit 1. i. The patient has taken any medication that does not belong to the allowed within the 14 days prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The clinical evaluation of the laboratory information will be tabulated Measure:Tolerability of montelukast in oral granules (once-a-day doses of 4 mg and 8 mg) in children 3 to 6 months of age. Timepoints:7 days ; Outcome name:The clinical evaluation of the laboratory information will be tabulated Measure:Tolerability of montelukast in oral granules (once-a-day doses of 4 mg and 8 mg) in children 3 to 6 months of age. Timepoints:7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Physical exams, vital signs, serum chemistry and a complete blood count Measure:Safety in oral granules (once-a-day doses of 4 mg and 8 mg) in children 3 to 6 months of age. Timepoints:7 days | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed