MK0476 Study in Adult Patients With Allergic Rhinitis

This study has been completed.

First Received: March 9, 2007 No Changes Posted

Sponsor:	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

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-

Resource links provided by NLM:

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

No publications provided

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

Additional relevant MeSH terms:

Respiratory System Agents
Otorhinolaryngologic Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Rhinitis

Nose Diseases
Pharmacologic Actions
Leukotriene Antagonists
Montelukast
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010