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

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

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Key information

Conditions

Rhinitis, Allergic, Seasonal Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

15 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

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

Other names: MK0476, Singulair

Comparator: pranlukast

Drug

Pranlukast 225 mg BID 2-weeks.

Primary outcomes

Composite Nasal Symptom Score

Secondary outcomes

Daytime nasal symptom score, Nighttime nasal symptom score

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Aug 8, 2005
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed