MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)

Phase 2CompletedNCT00446186

Organon and Co945 enrolled

Overview

The clinical study evaluates the efficacy and safety of MK0476 in adult patients with allergic rhinitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

945

Conditions

Rhinitis Allergic

Interventions

MK0476, montelukast sodium / Duration of Treatment: 2 WeeksDRUG

Comparator: placebo / Duration of Treatment: 2 WeeksDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients with seasonal allergic rhinitis Exclusion Criteria: * Patients who have nasal diseases (e.g., nasal polyp, septonasal arcuation, hypertrophic rhinitis), upper respiratory infection, sinusitis, infectious rhinitis, ocular infection and those disease severe enough to interfere with assessment of effectiveness * Patients who have rhinitis medicamentosa, or nonallergic rhinitis (e.g., vasomotor rhinitis, eosinophilia rhinitis) * Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease

Outcomes

Primary Outcomes

The change from baseline in the composite nasal symptoms score (average over the 2-week treatment period) in seasonal allergic rhinitis

Data from ClinicalTrials.gov

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