OC000459 Dose Finding Study in Hay Fever Sufferers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697281
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : February 24, 2009
Information provided by:
Oxagen Ltd

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: 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 Type : Interventional  (Clinical Trial)
Estimated 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 2008
Primary Completion Date : July 2008
Study Completion Date : September 2008

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

Primary Outcome Measures :
  1. Total nasal symptom score (TNSS) [ Time Frame: After 8 days of treatment ]

Secondary Outcome Measures :
  1. Other symptom scores of allergic rhinitis [ Time Frame: After 8 days of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697281

Allergie Zentrum Wien West, Vienna Challenge Chamber
Vienna, Austria, 1150 VIENNA
Sponsors and Collaborators
Oxagen Ltd
Principal Investigator: Univ Prof. Dr. Friedrich Horak, MD Allergie Zentrum Wien West

Responsible Party: Dr C Mike Perkins, Oxagen Ltd Identifier: NCT00697281     History of Changes
Other Study ID Numbers: OC000459/010/07
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009

Keywords provided by Oxagen Ltd:
allergic rhinitis
clinical trial
challenge test

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs