MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)

Organon

Status and phase: Completed; Phase 2

Conditions: Rhinitis Allergic

Treatments: Drug: Comparator: placebo / Duration of Treatment: 2 Weeks; Drug: MK0476, montelukast sodium / Duration of Treatment: 2 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00446186

2007_009

0476-378

Details and patient eligibility

About

The clinical study evaluates the efficacy and safety of MK0476 in adult patients with allergic rhinitis.

Enrollment: 945 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with seasonal allergic rhinitis

Exclusion criteria

• Patients who have nasal diseases (e.g., nasal polyp, septonasal arcuation, hypertrophic rhinitis), upper respiratory infection, sinusitis, infectious rhinitis, ocular infection and those disease severe enough to interfere with assessment of effectiveness
• Patients who have rhinitis medicamentosa, or nonallergic rhinitis (e.g., vasomotor rhinitis, eosinophilia rhinitis)
• Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind