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

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