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

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Organon

Status and phase

Completed
Phase 3

Conditions

Rhinitis, Allergic, Seasonal

Treatments

Drug: Comparator: pranlukast
Drug: montelukast sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00127647
2005_038
MK0476-327
0476-327

Details and patient eligibility

About

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

Enrollment

1,375 patients

Sex

All

Ages

15 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)

Exclusion criteria

  • Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,375 participants in 3 patient groups

1
Experimental group
Description:
montelukast sodium 5 mg, QD 2-weeks
Treatment:
Drug: montelukast sodium
2
Experimental group
Description:
montelukast sodium 10 mg QD 2-weeks
Treatment:
Drug: montelukast sodium
3
Active Comparator group
Description:
Pranlukast 225 mg BID 2-weeks
Treatment:
Drug: Comparator: pranlukast

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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