An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

Organon and Co1,375 enrolled

Overview

The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,375

Conditions

Rhinitis, Allergic, Seasonal

Interventions

montelukast sodiumDRUG

montelukast sodium; 5 mg, 10 mg QD 2-weeks.

Comparator: pranlukastDRUG

Pranlukast 225 mg BID 2-weeks.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress) Exclusion Criteria: * Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period

Outcomes

Primary Outcomes

Composite Nasal Symptom Score

Secondary Outcomes

Daytime nasal symptom score, Nighttime nasal symptom score

Data from ClinicalTrials.gov

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