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

NCT ID: NCT00972738

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2001-07-31

Brief Summary

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.

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 at bedtime for 2 weeks.

2

loratadine

Group Type: ACTIVE_COMPARATOR

Comparator: loratadine

Intervention Type: DRUG

Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.

3

placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

placebo tablet orally once daily at bedtime for 2 weeks

Interventions

montelukast sodium

Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.

Intervention Type: DRUG

Comparator: loratadine

Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.

Intervention Type: DRUG

Comparator: Placebo

placebo tablet orally once daily at bedtime for 2 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• 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, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22. doi: 10.1016/S1081-1206(10)62144-8.

Reference Type: BACKGROUND

PMID: 12602669 (View on PubMed)

Other Identifiers

MK0476-235

Identifier Type: -

Identifier Source: secondary_id

2009_658

Identifier Type: -

Identifier Source: secondary_id

0476-235

Identifier Type: -

Identifier Source: org_study_id