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

NCT00972738 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1214

Last updated 2022-02-03

Study results available
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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

Interventions

DRUG

montelukast sodium

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

DRUG

Comparator: loratadine

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

DRUG

Comparator: Placebo

placebo tablet orally once daily at bedtime 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
2001-04-30
Primary Completion
2001-07-31
Completion
2001-07-31

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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 NCT00972738 on ClinicalTrials.gov