MK0476 Study in Adult Patients With Perennial Allergic Rhinitis (0476-397)(COMPLETED)

MK0476 Phase III Long-term Study -Perennial Allergic Rhinitis-

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00771160

Enrollment

120

Registered

2008-10-13

Start date

2004-09-30

Completion date

2005-02-28

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

A clinical study evaluates the efficacy and safety of MK0476 in adult patients with Perennial Allergic rhinitis.

Interventions

DRUGmontelukast sodium

Arm 1: montelukast tablet 5 mg, QD. Treatment period is 12-weeks. Arm 2: montelukast tablet 10 mg, QD. Treatment period is 12-weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult Patients With Perennial Allergic Rhinitis

Exclusion criteria

* Patients Who Have Nasal Diseases (E.G., Nasal Polyp, Septonasal Arcuation, Hypertrophic Rhinitis), Upper Respiratory Infection, Sinusitis, Infectious Rhinitis 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
Any clinical or laboratory adverse experience	12 weeks

Secondary

Measure	Time frame
The daily mean of the composite nasal symptoms score at each of biweekly visits during the treatment period (average over the previous 2 weeks) or at time of termination	12 weeks

Outcome results

None listed

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