We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00446186
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The clinical study evaluates the efficacy and safety of MK0476 in adult patients with allergic rhinitis.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 945 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mk0476 Phase II Dose Finding Study -Allergic Rhinitis-
Study Start Date : February 2004
Primary Completion Date : March 2004
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. The change from baseline in the composite nasal symptoms score (average over the 2-week treatment period) in seasonal allergic rhinitis

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446186

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00446186     History of Changes
Other Study ID Numbers: 0476-378
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action