A RANDOMIZED, 3-PERIOD, MULTI-DOSE, MULTICENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND CONCENTRATION PROFILE IN PLASMA OF MONTELUKAST ADMINISTERED ONCE A DAY IN ORAL GRANULES TO CHILDREN FROM 1 TO 3 MONTHS OF AGE
- Conditions
- -J451 Nonallergic asthmaNonallergic asthmaJ451
- Registration Number
- PER-085-04
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient is a boy or girl> 1 month and <3 months of age at the time of administration of the drug.
• The parent / legal guardian agrees that the patient participate in the study as indicated by the signature of the parent / legal guardian in the consent form. The patient and the parent / legal guardian are willing to comply with the procedures and are able to comply with the scheduled clinic visits.
• It is considered that the patient has otherwise a good health according to the medical history and physical examination.
• The patient is within 5 ° to 95 ° percentile of statue and weight for his age according to Appendix 3, but weighs at least 3.5 kg.
• The patient has been fed powdered milk at least twice before the administration of the drug in Visit 2.
• The patient has active bronchiolitis or a history of bronchiolitis and asthma-like symptoms.
• The person in charge of the care (parent / guardian) is, in the opinion of the investigator, mentally or legally incapacitated, which prevents informed consent from being obtained.
• The patient has a history of any of the following medical conditions: Cystic fibrosis, Tuberculosis, Foreign body aspiration, Bronchopulmonary dysplasia, Tracheomalacia, Tracheoesophageal fistula, Gastroesophageal reflux, Pertussis, Congenital heart disease
• The patient has a history of any disease that, in the opinion of the investigator, could confuse the results of the study or pose additional risks if montelukast is administered to the patient.
• The gestational age of the patient at birth was less than 36 weeks.
• The patient has significant or unexplained abnormalities in the pre-study physical examination and / or laboratory safety measurements
• The patient is in a situation (for example, unreliable care of the adoptive parents, moving) or sees a condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
• The patient has a history of any clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or has a lung disease other than labronchiolitis and asthma-like symptoms.
• The patient has a history of any clinically significant adverse event of a serious nature related to the administration of either a commercialized or investigational drug (eg, angioedema, anaphylaxis).
• The patient has undergone surgery or participated in another clinical trial within 4 weeks prior to Visit 1.
• The patient has taken any medication other than the permitted medications (Section I.E.2.C.) within 14 days prior to Visit 1.
• The patient has used astemizole at any time before Visit 1.
• The patient has used any macrolide antibiotic (except azithromycin), azole fungicides, rifampin, theophylline preparations, terfenadine and / or loratadine within 10 days prior to Visit 1.
• The patient has used any oral p-agonist within 24 hours prior to the first dosing with montelukast at Visit 2.
• The patient is allergic to milk powder.
• The patient is anemic (ie, has a hemoglobin or hematocrit level below the normal range) or has an intravascular volume status that would not allow the blood sampling required for the pharmacokinetic analysis, as assessed by the investigator.
• The patient is nursing and the mother is taking some medication that inhibits or induces the metabolism of CYP3A4.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Through the tabulation of adverse events and the clinical evaluation of safety information<br>Measure:Safety and tolerability of montelukast oral granules<br>Timepoints:During treatment<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The pharmacokinetic parameter of the population, the AUCpop, will be evaluated<br>Measure:Estimated AUC of the 4 mg montelukast population in oral granules<br>Timepoints:During treatment<br>;<br>Outcome name:They will be compared with those from historical pediatric data of children 3 to 24 months of age who were similarly analyzed<br>Measure:Population pharmacokinetic parameters (AUCpop, Cmax, Tmax and T1 / 2 apparent elimination) of 4 mg montelukast in oral granules.<br>Timepoints:During treatment<br>