An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00127647

Enrollment

1375

Registered

2005-08-08

Start date

2004-11-30

Completion date

2005-04-30

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, Seasonal

Brief summary

The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

Interventions

DRUGmontelukast sodium

montelukast sodium; 5 mg, 10 mg QD 2-weeks.

DRUGComparator: pranlukast

Pranlukast 225 mg BID 2-weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)

Exclusion criteria

* Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period

Design outcomes

Primary

Measure	Time frame
Composite Nasal Symptom Score	—

Secondary

Measure	Time frame
Daytime nasal symptom score, Nighttime nasal symptom score	—

Outcome results

None listed

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