Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

Organon

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Comparator: placebo; Drug: Comparator: montelukast; Drug: Comparator: montelukast/loratadine; Drug: Comparator: loratadine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00979901

0476A-162

2009_664

MK0476A-162

Details and patient eligibility

About

This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.

Enrollment: 1,577 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season
• Patient is a nonsmoker and has been a nonsmoker for at least 1 year
• Patient is in good general health

Exclusion criteria

• Patient is hospitalized
• Patient is a woman who is less than 8 weeks postpartum or is breast-feeding
• Patient intends to move or vacation away during the study
• Patient has had any major surgery within 4 weeks of study start
• Patient is a current or past abuser of alcohol or illicit drugs
• Patient has been treated in an emergency room for asthma in the past month
• Patient had an upper respiratory infection with in 3 weeks prior to study start

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,577 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

montelukast

Treatment:

Drug: Comparator: montelukast

2

Experimental group

Description:

loratadine

Treatment:

Drug: Comparator: loratadine

3

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: placebo

4

Experimental group

Description:

montelukast/loratadine

Treatment:

Drug: Comparator: montelukast/loratadine