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

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

Completed

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Key information

Conditions

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

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MK0476, montelukast sodium / Duration of Treatment: 2 Weeks

Drug

Comparator: placebo / Duration of Treatment: 2 Weeks

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Mk0476 Phase II Dose Finding Study -Allergic Rhinitis-

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Mar 12, 2007
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