A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

829 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2000-11-30

Brief Summary

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A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

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

Group Type EXPERIMENTAL

montelukast sodium

Intervention Type DRUG

montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks

2

loratadine

Group Type ACTIVE_COMPARATOR

Comparator: loratadine

Intervention Type DRUG

loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks

3

placebo

Group Type PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type DRUG

placebo tablet, taken orally once daily at bed time for 2 weeks

Interventions

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montelukast sodium

montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks

Intervention Type DRUG

Comparator: loratadine

loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks

Intervention Type DRUG

Comparator: placebo

placebo tablet, taken orally once daily at bed time for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
* Patient is a non-smoker
* Patient is in good mental and physical health

Exclusion Criteria

* Patient is hospitalized
* Patient is a woman who is \<8 weeks postpartum or is breast feeding
* Patient intends to move or vacation away during the study
* Patient is a current or past abuser of alcohol or illicit drugs

Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No