Status:
COMPLETED
Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)
Lead Sponsor:
Organon and Co
Conditions:
Perennial Allergic Rhinitis
Eligibility:
All Genders
1-15 years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The primary hypothesis of ...
Eligibility Criteria
Inclusion
- Weight ≥8 kg
- Diagnosis of PAR and has symptoms of PAR at Visit 1
Exclusion
- Past or present medical history of asthma
- Diagosis of acute rhinitis, simple rhinitis, rhinitis congestive, rhinitis atrophic, sinusitis with purulent nasal discharge, rhinitis medicamentosa or nonallergic rhinitis (e.g. vasomotor rhinitis, eosinophilic rhinitis)
- Started hyposensitization therapy or non-specific immunotherapy within 6 months prior to Visit 1
- Medical history of inferior concha mucosal resection, submucous resection of inferior turbinates or other surgery aimed at reduction and/or modulation of nasal mucosa (including electrocoagulation, cryoextraction or application of trichloroacetic acid)
- Clinically significant, active disease of the cardiovascular or hematologic systems or uncontrolled hypertension (1 to 5 year olds: \>120/70 mmHg; 6 to 9 year olds: \>130/80 mmHg; 10 to 15 year olds: \>140/85 mmHg)
- Medical history of stunted growth
- Serious drug allergy
- Treated with other clinical study drug within 3 months prior to Visit 1
Key Trial Info
Start Date :
June 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2013
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01852812
Start Date
June 7 2013
End Date
December 24 2013
Last Update
June 18 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.