STUDY RANDOMIZED, OF 3 PERIODS OF MULTIPLE DOSE, MULTICENTRIC TO EVALUATE THE SAFETY, TOLERABILITY AND THE PROFILE OF PLASMA CONCENTRATION OF MONTELUKAST ADMINSTRATED ONCE A DAY IN ORAL GRANULES TO CHILDREN FROM 3 TO 6 MONTHS OF AGE.

Phase 1

• Conditions: Acute bronchiolitis, unspecified; J219; -J219 Acute bronchiolitis, unspecified

• Registration Number: PER-042-03
• Lead Sponsor: MERCK & CO.INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-08-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The clinical evaluation of the laboratory information will be tabulated<br>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.<br>Timepoints:7 days<br>;<br>Outcome name:The clinical evaluation of the laboratory information will be tabulated<br>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.<br>Timepoints:7 days<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Physical exams, vital signs, serum chemistry and<br>a complete blood count<br>Measure:Safety in oral granules (once-a-day doses of 4 mg and 8 mg) in children 3 to 6 months of age.<br><br>Timepoints:7 days<br>