Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

Organon

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972738

2009_658

MK0476-235

0476-235

Details and patient eligibility

About

This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.

Enrollment: 1,214 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a documented history of season allergic rhinitis symptoms that flare up during the study season
• 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 has had major surgery in the past 4 weeks
• 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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1,214 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