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Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

NCT00974571 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1365

Last updated 2022-02-03

Study results available
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Summary

This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

montelukast sodium

montelukast 10 mg tablet orally once daily at bedtime for 6 weeks

DRUG

Comparator: cetirizine

cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks

DRUG

Comparator: placebo

placebo tablet orally once daily at bedtime for 6 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
2001-11-30
Primary Completion
2002-05-31
Completion
2002-05-31

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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 NCT00974571 on ClinicalTrials.gov