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

Mk0476 Phase II Dose Finding Study -Allergic Rhinitis-

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00446186

Enrollment

945

Registered

2007-03-12

Start date

2004-02-29

Completion date

2004-03-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis Allergic

Brief summary

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

Interventions

DRUGMK0476, montelukast sodium / Duration of Treatment: 2 Weeks

DRUGComparator: placebo / Duration of Treatment: 2 Weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026