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Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

NCT00963599 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 907

Last updated 2022-02-09

Study results available
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Summary

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

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Comparator: montelukast/loratadine

montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks

DRUG

Comparator: montelukast

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

DRUG

Comparator: loratadine

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

DRUG

Comparator: placebo

placebo tablet taken 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
1999-09-30
Primary Completion
1999-11-30
Completion
1999-11-30

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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 NCT00963599 on ClinicalTrials.gov