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An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

NCT00127647 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1375

Last updated 2024-08-15

No results posted yet for this study

Summary

The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

Conditions

  • Rhinitis, Allergic, Seasonal

Interventions

DRUG

montelukast sodium

montelukast sodium; 5 mg, 10 mg QD 2-weeks.

DRUG

Comparator: pranlukast

Pranlukast 225 mg BID 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
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-04-30
Completion
2005-04-30

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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 NCT00127647 on ClinicalTrials.gov