OC000459 Dose Finding Study in Hay Fever Sufferers.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-09-30

Brief Summary

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

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Detailed Description

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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

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Dose level 1

Group Type EXPERIMENTAL

OC000459

Intervention Type DRUG

Tablets twice daily for 8 days

Dose level 1

2

Dose level 2

Group Type EXPERIMENTAL

OC000459

Intervention Type DRUG

Tablets twice daily for 8 days

Dose level 2

3

Dose level 3

Group Type EXPERIMENTAL

OC000459

Intervention Type DRUG

Tablets twice daily for 8 days

Dose level 3

4

Dose level 4

Group Type EXPERIMENTAL

OC000459

Intervention Type DRUG

Tablets twice daily for 8 days

Dose level 4

5

Dose level 5

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Tablets twice daily for 8 days

Dose level 5

Interventions

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OC000459

Tablets twice daily for 8 days

Dose level 1

Intervention Type DRUG

OC000459

Tablets twice daily for 8 days

Dose level 2

Intervention Type DRUG

OC000459

Tablets twice daily for 8 days

Dose level 3

Intervention Type DRUG

OC000459

Tablets twice daily for 8 days

Dose level 4

Intervention Type DRUG

Placebo

Tablets twice daily for 8 days

Dose level 5

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No