NCT00697281

OC000459 Dose Finding Study in Hay Fever Sufferers.

A Dose Finding Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Oxagen Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis

Detailed description

This will be a randomised, double blind, placebo controlled, parallel group evaluation of OC000459 given orally for eight days. Four dose levels will be studied and compared to placebo. They will be studied in treatment groups of 18 to 21 subjects. The placebo group will also consist of 18 to 21 subjects. There will be a screening period of up to six weeks. There will be a follow up one to three weeks after the last dose of study drug.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	OC000459	Tablets twice daily for 8 days Dose level 1
DRUG	OC000459	Tablets twice daily for 8 days Dose level 2
DRUG	OC000459	Tablets twice daily for 8 days Dose level 3
DRUG	OC000459	Tablets twice daily for 8 days Dose level 4
DRUG	Placebo	Tablets twice daily for 8 days Dose level 5

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-07-01
• Completion: 2008-09-01
• First posted: 2008-06-13
• Last updated: 2009-02-24

Locations

1 site across 1 country: Austria