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

Organon

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960141

2009_633

MK0476-192

0476-192

Details and patient eligibility

About

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.

Enrollment: 829 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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829 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

montelukast

Treatment:

Drug: montelukast sodium

2

Active Comparator group

Description:

loratadine

Treatment:

Drug: Comparator: loratadine

3

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: placebo