Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)

Organon

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: Montelukast Oral Granules (OG); Drug: Montelukast Chewable Tablets (CT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01852812

132233 (Registry Identifier)

0476-520

Details and patient eligibility

About

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 this study is that montelukast oral granules (OG) and chewable tablets (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.

Enrollment: 87 patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Weight ≥8 kg
• Diagnosis of PAR and has symptoms of PAR at Visit 1

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups

Montelukast 4 mg OG/1-5 year olds

Experimental group

Description:

Participants receive montelukast 4 mg OG in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)

Treatment:

Drug: Montelukast Oral Granules (OG)

Montelukast 5 mg CT/6-9 year olds

Experimental group

Description:

Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks

Treatment:

Drug: Montelukast Chewable Tablets (CT)

Montelukast 5 mg CT/10-15 year olds

Experimental group

Description:

Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks

Treatment:

Drug: Montelukast Chewable Tablets (CT)