Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Oxagen Ltd |
---|---|
Information provided by: | Oxagen Ltd |
ClinicalTrials.gov Identifier: | NCT00697281 |
The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis
Condition | Intervention | Phase |
---|---|---|
Allergic Rhinitis |
Drug: OC000459 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 120 |
Study Start Date: | May 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Dose level 1
|
Drug: OC000459
Tablets twice daily for 8 days Dose level 1 |
2: Experimental
Dose level 2
|
Drug: OC000459
Tablets twice daily for 8 days Dose level 2 |
3: Experimental
Dose level 3
|
Drug: OC000459
Tablets twice daily for 8 days Dose level 3 |
4: Experimental
Dose level 4
|
Drug: OC000459
Tablets twice daily for 8 days Dose level 4 |
5: Experimental
Dose level 5
|
Drug: Placebo
Tablets twice daily for 8 days Dose level 5 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Acceptable contraception includes the use of TWO of the following:
Exclusion Criteria:
Austria | |
Allergie Zentrum Wien West, Vienna Challenge Chamber | |
Vienna, Austria, 1150 VIENNA |
Principal Investigator: | Univ Prof. Dr. Friedrich Horak, MD | Allergie Zentrum Wien West |
Responsible Party: | Oxagen Ltd ( Dr C Mike Perkins ) |
Study ID Numbers: | OC000459/010/07 |
Study First Received: | June 11, 2008 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00697281 |
Health Authority: | Austria: Agency for Health and Food Safety |
allergic rhinitis human clinical trial |
efficacy safety challenge test |
Fever Signs and Symptoms Otorhinolaryngologic Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Rhinitis, Allergic, Seasonal Rhinitis |
Nose Diseases |