Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: epinastine nasal spray, low concentration, low dose volume; Other: placebo nasal spray; Drug: epinastine nasal spray, low concentration, high dose volume; Drug: epinastine nasal spray, high concentration, low dose volume; Drug: epinastine nasal spray, high concentration, high dose volume

Study type: Interventional

Funder types: Industry

Identifiers

NCT00564421

P08648

033-103

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis

Enrollment: 798 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Significant medical condition
• Significant nasal abnormality
• Significant cardiac condition
• Recent infection
• Use of other allergy medication during the study
• Use of asthma medication other than as-needed albuterol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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798 participants in 5 patient groups, including a placebo group

Epinastine low concentration:low dose volume

Experimental group

Treatment:

Drug: epinastine nasal spray, low concentration, low dose volume

Epinastine low concentration:high dose volume

Experimental group

Treatment:

Drug: epinastine nasal spray, low concentration, high dose volume

Epinastine high concentration:low dose volume

Experimental group

Treatment:

Drug: epinastine nasal spray, high concentration, low dose volume

Epinastine high concentration:high dose volume

Experimental group

Treatment:

Drug: epinastine nasal spray, high concentration, high dose volume

Placebo nasal spray

Placebo Comparator group

Treatment:

Other: placebo nasal spray