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A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis

NCT ID: NCT01448902

Last Updated: 2011-10-07

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-05-31

Brief Summary

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The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a randomised, double blind, placebo controlled, two way crossover evaluation. There will be a screening period of up to three weeks and a washout period of at least one week between the two treatment periods. There will be a follow up one to three weeks after the last dose of study drug.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OC000459

Group Type EXPERIMENTAL

OC000459

Intervention Type DRUG

OC000459 200mg bid for 8 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo bid for 8 days

Interventions

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OC000459

OC000459 200mg bid for 8 days

Intervention Type DRUG

Placebo

Placebo bid for 8 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
* Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
* FEV1 within normal limits (≥90% of predicted).
* Atopy defined by a positive cutaneous response to mixed grass pollen within the last 12 months or at screening.
* Asymptomatic at screening
* Non smokers for at least the past 12 months

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.
* Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function
* Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Oxagen Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Friedrich Horak, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Vienna Challenge Chamber

Locations

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Vienna Challenge Chamber

Vienna, , Austria

Site Status

Countries

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Austria

References

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Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Collins LP, Hunter MG, Steiner J, Lewis T, Payton MA, Perkins CM, Pettipher R. The CRTH2 antagonist OC000459 reduces nasal and ocular symptoms in allergic subjects exposed to grass pollen, a randomised, placebo-controlled, double-blind trial. Allergy. 2012 Dec;67(12):1572-9. doi: 10.1111/all.12042. Epub 2012 Oct 1.

Reference Type DERIVED
PMID: 23025511 (View on PubMed)

Other Identifiers

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2007-000017-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OC000459/007/06

Identifier Type: -

Identifier Source: org_study_id