Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

Organon

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00974571

MK0476-246

2009_659

0476-246

Details and patient eligibility

About

This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

Enrollment: 1,365 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a documented clinical history of perennial allergic rhinitis
• Patient is a nonsmoker
• Patient is in good general health

Exclusion criteria

• Patient is hospitalized
• Patient is a woman who is <8 weeks postpartum or is breast-feeding
• 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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1,365 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

montelukast

Treatment:

Drug: montelukast sodium

2

Active Comparator group

Description:

cetirizine

Treatment:

Drug: Comparator: cetirizine

3

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: placebo