Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
NCT ID: NCT01057927
Last Updated: 2010-01-28
Study Results
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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COMPLETED
PHASE2
132 participants
INTERVENTIONAL
2007-01-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OC000459
OC000459
OC000459 capsules 2x100mg BID for 28 days
Placebo
Placebo
Placebo capsules to match OC000459 100mg capsules, 2 tablets BID
Interventions
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OC000459
OC000459 capsules 2x100mg BID for 28 days
Placebo
Placebo capsules to match OC000459 100mg capsules, 2 tablets BID
Eligibility Criteria
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Inclusion Criteria
* Non smokers
* Mild to moderate asthmatics according to GINA guidelines for at least 12 months.
* History of asthma symptoms increasing in response to external allergens.
* Testing positive on skin prick test to an allergen associated with the subject's asthma
Exclusion Criteria
* Receipt of prescribed or over the counter medication within 14 days of the first study day.
18 Years
55 Years
ALL
No
Sponsors
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Oxagen Ltd
INDUSTRY
Responsible Party
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Oxagen Ltd
Locations
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Research Institute of Pulmonology
Moscow, , Russia
Burdenko Main Military Hospital
Moscow, , Russia
City Hospital #23
Moscow, , Russia
City Hospital #7
Moscow, , Russia
Vishnevsky Central Military Hospital #3
Moscow, , Russia
Leningrad Regional Hospital
Saint Petersbrug, , Russia
St George City Hospital
Saint Petersbrug, , Russia
St Petersburg Medical Academy of Postgraduate Education
Saint Petersburg, , Russia
St Petersburg Medical Academy
Saint Petersburg, , Russia
Outpatient Clinic #94
Saint Petersburg, , Russia
St Petersbrug Hospital of the Russian Academy of Science
Saint Petersburg, , Russia
Russian Center of Emergency and Radiology Medicine
Saint Petersburg, , Russia
St Petersburg State Pediatrics Academy
Saint Petersburg, , Russia
Central Medical Unit #122
Saint Petersburg, , Russia
St George City Hospital
Saint Petersburg, , Russia
Sverdlovsk Regional Hospital #1
Yekaterinburg, , Russia
Countries
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References
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Barnes N, Pavord I, Chuchalin A, Bell J, Hunter M, Lewis T, Parker D, Payton M, Collins LP, Pettipher R, Steiner J, Perkins CM. A randomized, double-blind, placebo-controlled study of the CRTH2 antagonist OC000459 in moderate persistent asthma. Clin Exp Allergy. 2012 Jan;42(1):38-48. doi: 10.1111/j.1365-2222.2011.03813.x. Epub 2011 Jul 15.
Other Identifiers
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OC000459/006/06
Identifier Type: -
Identifier Source: org_study_id