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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Rhinitis, Allergic, Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

montelukast sodium 5 mg, QD 2-weeks

Group Type EXPERIMENTAL

montelukast sodium

Intervention Type DRUG

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

2

montelukast sodium 10 mg QD 2-weeks

Group Type EXPERIMENTAL

montelukast sodium

Intervention Type DRUG

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

3

Pranlukast 225 mg BID 2-weeks

Group Type ACTIVE_COMPARATOR

Comparator: pranlukast

Intervention Type DRUG

Pranlukast 225 mg BID 2-weeks.

Interventions

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montelukast sodium

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

Intervention Type DRUG

Comparator: pranlukast

Pranlukast 225 mg BID 2-weeks.

Intervention Type DRUG

Other Intervention Names

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MK0476 Singulair

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No