MK0476 Study in Adult Patients With Allergic Rhinitis

This study has been completed.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00446186

Purpose

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

Condition	Intervention	Phase
Rhinitis Allergic	Drug: MK0476, montelukast sodium / Duration of Treatment: 2 Weeks Drug: Comparator: placebo / Duration of Treatment: 2 Weeks	Phase II

Drug Information available for: Montelukast sodium Montelukast

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Mk0476 Phase II Dose Finding Study -Allergic Rhinitis-

Further study details as provided by Merck:

Primary Outcome Measures:

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

Estimated Enrollment:	780
Study Start Date:	February 2004

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446186

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2007_009
Study First Received:	March 9, 2007
Last Updated:	March 9, 2007
ClinicalTrials.gov Identifier:	NCT00446186
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Montelukast
Signs and Symptoms
Otorhinolaryngologic Diseases
Respiratory Tract Infections

Respiratory Tract Diseases
Rhinitis
Leukotriene Antagonists

Additional relevant MeSH terms:

Respiratory System Agents
Therapeutic Uses
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009