NCT00446186

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
945

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2007

Completed
Last Updated

August 15, 2024

Status Verified

January 1, 2022

Enrollment Period

29 days

First QC Date

March 9, 2007

Last Update Submit

August 12, 2024

Conditions

Rhinitis Allergic

Outcome Measures

Primary Outcomes (1)

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

Interventions

MK0476, montelukast sodium / Duration of Treatment: 2 WeeksDRUG
Comparator: placebo / Duration of Treatment: 2 WeeksDRUG

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with seasonal allergic rhinitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Okubo K, Baba K. A double-blind non-inferiority clinical study of montelukast, a cysteinyl leukotriene receptor 1 antagonist, compared with pranlukast in patients with seasonal allergic rhinitis. Allergol Int. 2008 Dec;57(4):383-90. doi: 10.2332/allergolint.O-08-533. Epub 2008 Nov 1.

    PMID: 18946234RESULT

  • Okubo K, Baba K. Therapeutic effect of montelukast, a cysteinyl leukotriene receptor 1 antagonist, on Japanese patients with seasonal allergic rhinitis. Allergol Int. 2008 Sep;57(3):247-55. doi: 10.2332/allergolint.O-07-515. Epub 2008 Jul 1.

    PMID: 18566548RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

montelukastDuration of Therapy

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2007

First Posted

March 12, 2007

Study Start

February 1, 2004

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

August 15, 2024

Record last verified: 2022-01