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

NCT ID: NCT00963469

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1079 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2001-11-30

Brief Summary

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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

montelukast

Group Type: EXPERIMENTAL

montelukast sodium

Intervention Type: DRUG

montelukast 10 mg tablet orally once daily in the morning for 4 weeks

2

loratadine

Group Type: ACTIVE_COMPARATOR

Comparator: loratadine

Intervention Type: DRUG

loratadine 10 mg tablet orally once daily in the morning for 4 weeks

3

placebo

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: DRUG

placebo tablet orally once daily in the morning for 4 weeks

Interventions

montelukast sodium

montelukast 10 mg tablet orally once daily in the morning for 4 weeks

Intervention Type: DRUG

Comparator: loratadine

loratadine 10 mg tablet orally once daily in the morning for 4 weeks

Intervention Type: DRUG

Comparator: placebo

placebo tablet orally once daily in the morning for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. doi: 10.1046/j.1398-9995.2003.00261.x.

Reference Type: BACKGROUND

PMID: 14616102 (View on PubMed)

Other Identifiers

MK0476-240

Identifier Type: -

Identifier Source: secondary_id

2009_647

Identifier Type: -

Identifier Source: secondary_id

0476-240

Identifier Type: -

Identifier Source: org_study_id