Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

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

NCT00963469

MK0476-240

2009_647

0476-240

Details and patient eligibility

About

This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.

Enrollment: 1,079 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a history of seasonal allergic rhinitis that worsens during the study season
• Patient is a nonsmoker
• Patient is in good health physical and mental health

Exclusion criteria

• Patient is hospitalized
• Patient is a woman who is < 8 weeks postpartum or is breastfeeding
• Patient plans to move or vacation away during the study
• Patient has had any major surgery with in past 4 weeks
• 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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1,079 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