Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)

Organon

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Placebo; Drug: Montelukast

Study type: Interventional

Funder types: Industry

Identifiers

NCT01857063

132232 (Registry Identifier)

0476-519

Details and patient eligibility

About

This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in SAR.

Enrollment: 220 patients

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Weight: ≥ 25 kg
• Height: ≥ 125 cm
• Able to record symptoms in a diary
• Has had allergic rhinitis symptoms [Japanese Cedar (JC) pollinosis]
• Tested positive for JC pollen specific immunoglobulin E (IgE) antibody assay

Exclusion criteria

• Has nasal findings that would interfere with evaluating nasal congestion symptoms
• Past or present medical history of bronchial asthma
• Medical history of allergies except allergic rhinitis and has possibility of dramatically worsening of these symptoms induced by JC pollen exposure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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220 participants in 2 patient groups

Montelukast/Placebo

Experimental group

Description:

Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.

Treatment:

Drug: Montelukast

Drug: Placebo

Placebo/Montelukast

Experimental group

Description:

Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.

Treatment:

Drug: Montelukast

Drug: Placebo