NCT01748344

Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis

A Randomised, Placebo Controlled, Four Period Crossover Study to Evaluate the Efficacy, Safety of Oral Repeat Doses of ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis in the Vienna Challenge Chamber.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled conditions.

Detailed description

The purpose of this study is to investigate if ONO-4053 will impact allergic rhinitis symptoms in subjects with seasonal allergic rhinitis when they are exposed to pollen administered at a fixed rate in an inhalation exposure chamber compared to the standard treatment Cetirizine 10mg under the same conditions.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Cetirizine	10mg tablets
DRUG	High dose ONO-4053	Experimental
DRUG	Low dose ONO-4053	Experimental
DRUG	Placebo	None active

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-02-01
• First posted: 2012-12-12
• Last updated: 2014-04-15

Locations

1 site across 1 country: Austria