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

NCT00963469 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1079

Last updated 2022-02-03

Study results available
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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

Interventions

DRUG

montelukast sodium

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

DRUG

Comparator: loratadine

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

DRUG

Comparator: placebo

placebo tablet orally once daily in the morning for 4 weeks

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2001-11-30
Completion
2001-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00963469 on ClinicalTrials.gov