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

Phase 3

Completed

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

• Registration Number: NCT00127647
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2005-08-04
• Study First Submitted QC: 2005-08-05
• Study First Posted: 2005-08-08
• Status Verified: 2022-01
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1375

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	montelukast sodium	montelukast sodium 10 mg QD 2-weeks
1	montelukast sodium	montelukast sodium 5 mg, QD 2-weeks

Primary Outcome Measures

Name	Time	Method
Composite Nasal Symptom Score

Secondary Outcome Measures

Name	Time	Method
Daytime nasal symptom score, Nighttime nasal symptom score