A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Epinastine Nasal Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00407927

033-101

Details and patient eligibility

About

The purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug compared to placebo for the treatment of subjects with seasonal allergic rhinitis.

Enrollment: 571 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A documented history of seasonal allergic rhinitis to mountain cedar pollen

Exclusion criteria

• Significant medical condition
• Cardiovascular abnormality
• Have a significant physical obstruction in the nose
• Started or had a change in immunotherapy within the 30 days prior to

screening

• Have nasal ulceration(s) or any active nasal bleeding
• Require use of allergy medications during the study
• Require use of asthma medications other than as needed albuterol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind