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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dose level 1 |
|
| 2 | Experimental | Dose level 2 |
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| 3 | Experimental | Dose level 3 |
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| 4 | Experimental | Dose level 4 |
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| 5 | Experimental | Dose level 5 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC000459 | Drug | Tablets twice daily for 8 days Dose level 1 |
| |
| OC000459 |
| Measure | Description | Time Frame |
|---|---|---|
| Total nasal symptom score (TNSS) | After 8 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Other symptom scores of allergic rhinitis | After 8 days of treatment |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Univ Prof. Dr. Friedrich Horak, MD | Allergie Zentrum Wien West | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergie Zentrum Wien West, Vienna Challenge Chamber | Vienna | 1150 VIENNA | Austria |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C571151 | (5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid |
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| Drug |
Tablets twice daily for 8 days Dose level 2 |
|
| OC000459 | Drug | Tablets twice daily for 8 days Dose level 3 |
|
| OC000459 | Drug | Tablets twice daily for 8 days Dose level 4 |
|
| Placebo | Drug | Tablets twice daily for 8 days Dose level 5 |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |