Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

NCT ID: NCT00979901

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1577 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31
• Study Completion Date: 2000-05-31

Brief Summary

This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.

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

Comparator: montelukast

Intervention Type: DRUG

10 mg montelukast tablet given once daily at bedtime for 2 weeks

2

loratadine

Group Type: EXPERIMENTAL

Comparator: loratadine

Intervention Type: DRUG

10 mg loratadine tablet given once daily at bedtime for 2 weeks

3

placebo

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: DRUG

placebo tablet given once daily at bedtime for 2 weeks

4

montelukast/loratadine

Group Type: EXPERIMENTAL

Comparator: montelukast/loratadine

Intervention Type: DRUG

montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks

Interventions

Comparator: montelukast

10 mg montelukast tablet given once daily at bedtime for 2 weeks

Intervention Type: DRUG

Comparator: loratadine

10 mg loratadine tablet given once daily at bedtime for 2 weeks

Intervention Type: DRUG

Comparator: placebo

placebo tablet given once daily at bedtime for 2 weeks

Intervention Type: DRUG

Comparator: montelukast/loratadine

montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season
• Patient is a nonsmoker and has been a nonsmoker for at least 1 year
• Patient is in good general health

Exclusion Criteria

• Patient is hospitalized
• Patient is a woman who is less than 8 weeks postpartum or is breast-feeding
• Patient intends to move or vacation away during the study
• Patient has had any major surgery within 4 weeks of study start
• Patient is a current or past abuser of alcohol or illicit drugs
• Patient has been treated in an emergency room for asthma in the past month
• Patient had an upper respiratory infection with in 3 weeks prior to study start

• 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

Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF, Ratner PH, Malice MP, Reiss TF; Montelukast Spring Rhinitis Study Group. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy. 2002 Jul;32(7):1020-8. doi: 10.1046/j.1365-2222.2002.01422.x.

Reference Type: RESULT

PMID: 12100048 (View on PubMed)

Other Identifiers

MK0476A-162

Identifier Type: -

Identifier Source: secondary_id

2009_664

Identifier Type: -

Identifier Source: secondary_id

0476A-162

Identifier Type: -

Identifier Source: org_study_id