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

Phase 3

Completed

• Conditions: Rhinitis, Allergic
• Interventions: Drug: montelukast sodium

• Registration Number: NCT00771160
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	montelukast sodium	MK0476 10mg
1	montelukast sodium	MK0476 5mg

Primary Outcome Measures

Name	Time	Method
Any clinical or laboratory adverse experience	12 weeks

Secondary Outcome Measures

Name	Time	Method
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	12 weeks