Clinical Trials Logo
  1. Home
  2. Bronchiolitis
  3. NCT00394069
  4. Details
NCT00394069 Clinical Trial

PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)

Bronchiolitis Clinical Trial

Official title:
A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 3 to 6 Months

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00394069
Other study ID # 0476-268
Secondary ID 2006_545
Status Completed
Phase Phase 2
First received
Last updated
Start date July 2003
Est. completion date December 2003

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 3 to 6 months of age with bronchiolitis.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date December 2003
Est. primary completion date December 2003
Accepts healthy volunteers No
Gender All
Age group 3 Months to 6 Months
Eligibility Inclusion Criteria : - Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms Exclusion Criteria : - A history of any significant illness that will pose additional risk to the patient

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK-0476, montelukast sodium
Duration of Treatment: 14 Days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Knorr B, Maganti L, Ramakrishnan R, Tozzi CA, Migoya E, Kearns G. Pharmacokinetics and safety of montelukast in children aged 3 to 6 months. J Clin Pharmacol. 2006 Jun;46(6):620-7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months. 14 days
Secondary To estimate the single-dose population pharmacokinetics, maximum plasma concentration, time to maximum plasma concentration, and apparent half-life of montelukast 4-mg oral granules in children aged 3 to 6 months. 24 hours
See also
  Status Clinical Trial Phase
Recruiting NCT04989114 - Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis N/A
Recruiting NCT06016244 - Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial N/A
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Recruiting NCT02366715 - Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research Phase 3
Terminated NCT02219334 - Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study N/A
Recruiting NCT01944995 - Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis N/A
Terminated NCT02834819 - Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis N/A
Terminated NCT01757496 - Cough Assist in Bronchiolitis N/A
Not yet recruiting NCT01414322 - Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients N/A
Completed NCT00369759 - An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants N/A
Completed NCT00347880 - Atrial and Brain Natriuretic Peptides in Bronchiolitis Phase 1
Recruiting NCT05548036 - A Feasibility RCT of Aerobika Verses ACBT in People With COPD N/A
Active, not recruiting NCT04302207 - The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study N/A
Completed NCT02858531 - Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics
Withdrawn NCT05994183 - The Bronchiolitis in Hospitalized Infants Study Early Phase 1
Terminated NCT03614507 - Automation Oxygen Flow Titration in Spontaneously Breathing Infants N/A
Completed NCT02856165 - High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis N/A
Recruiting NCT05909566 - Respiratory Support and Treatment for Efficient and Cost-Effective Care N/A
Recruiting NCT04437641 - Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children
Not yet recruiting NCT06083077 - Chest and Abdominal Wall Strapping in Infant With Bronchiolitis N/A