OC000459 Dose Finding Study in Hay Fever Sufferers.

Sponsor

Oxagen Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT00697281

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

29.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: OC000459 Drug: OC000459 Drug: OC000459 Drug: OC000459 Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Dose level 1	Drug: OC000459 Tablets twice daily for 8 days Dose level 1
Experimental: 2 Dose level 2	Drug: OC000459 Tablets twice daily for 8 days Dose level 2
Experimental: 3 Dose level 3	Drug: OC000459 Tablets twice daily for 8 days Dose level 3
Experimental: 4 Dose level 4	Drug: OC000459 Tablets twice daily for 8 days Dose level 4
Experimental: 5 Dose level 5	Drug: Placebo Tablets twice daily for 8 days Dose level 5

Outcome Measures

Primary Outcome Measures

Total nasal symptom score (TNSS) [After 8 days of treatment]

Secondary Outcome Measures

Other symptom scores of allergic rhinitis [After 8 days of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening.
Acceptable contraception includes the use of TWO of the following:
oral contraception (i.e. the Pill);
intrauterine device (an IUD or 'Coil');
barrier contraception (i.e. condoms or diaphragm/cap);
transdermal patch

Exclusion Criteria:

Medical conditions likely to affect the outcome of the study.
Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases as determined by the principal investigator or designee.
Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age).
Immunotherapy treatment course in the past 28 days
Use of inhaled or local corticosteroids in the past 28 days.