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A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

NCT00960141 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 829

Last updated 2022-02-03

Study results available
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Summary

A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

montelukast sodium

montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks

DRUG

Comparator: loratadine

loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks

DRUG

Comparator: placebo

placebo tablet, taken orally once daily at bed time for 2 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
2000-08-31
Primary Completion
2000-10-31
Completion
2000-11-30

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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 NCT00960141 on ClinicalTrials.gov