MK0476 Study in Adult Patients With Perennial Allergic Rhinitis (0476-397)(COMPLETED)

Phase 3CompletedNCT00771160

Organon and Co120 enrolled

Overview

A clinical study evaluates the efficacy and safety of MK0476 in adult patients with Perennial Allergic rhinitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Rhinitis, Allergic

Interventions

montelukast sodiumDRUG

Arm 1: montelukast tablet 5 mg, QD. Treatment period is 12-weeks. Arm 2: montelukast tablet 10 mg, QD. Treatment period is 12-weeks.

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult Patients With Perennial Allergic Rhinitis Exclusion Criteria: * Patients Who Have Nasal Diseases (E.G., Nasal Polyp, Septonasal Arcuation, Hypertrophic Rhinitis), Upper Respiratory Infection, Sinusitis, Infectious Rhinitis 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

Any clinical or laboratory adverse experience

Time frame: 12 weeks

Secondary Outcomes

The daily mean of the composite nasal symptoms score at each of biweekly visits during the treatment period (average over the previous 2 weeks) or at time of termination

Time frame: 12 weeks

Data from ClinicalTrials.gov

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