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Sponsored by: |
Oxagen Ltd |
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Information provided by: | Oxagen Ltd |
ClinicalTrials.gov Identifier: | NCT00890877 |
This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.
Condition | Intervention | Phase |
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Mild to Moderate Persistent Asthma |
Drug: OC000459 or placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Dose Finding Study in Patients With Mild to Moderate Persistent Asthma: A Parallel Group, Randomised, Placebo Controlled, Double Blind Assessment of Oral Oc000459 Dosed At Three Dose Schedules for Twelve Weeks Finding Study In Patients With Mild To Moderate Persistent Asthma |
Estimated Enrollment: | 480 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: OC000459 or placebo
Pills, active and/or placebo given twice daily for 17 weeks
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2: Experimental |
Drug: OC000459 or placebo
Pills, active and/or placebo given twice daily for 17 weeks
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3: Experimental |
Drug: OC000459 or placebo
Pills, active and/or placebo given twice daily for 17 weeks
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4: Experimental |
Drug: OC000459 or placebo
Pills, active and/or placebo given twice daily for 17 weeks
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: Dany Azzi, MD | Dany.Azzi@psi-cro.com |
Bulgaria | |
Research site | Not yet recruiting |
Sofia, Bulgaria | |
Hungary | |
Research site | Not yet recruiting |
Gyor, Hungary | |
Poland | |
Research site | Not yet recruiting |
Warsaw, Poland | |
Romania | |
Research site | Not yet recruiting |
Bucharest, Romania | |
Russian Federation | |
Research site | Recruiting |
Moscow, Russian Federation | |
Ukraine | |
Research site | Not yet recruiting |
Kiev, Ukraine |
Responsible Party: | Oxagen Ltd ( Dr C Mike Perkins ) |
Study ID Numbers: | OC000459/012/08 |
Study First Received: | April 29, 2009 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00890877 History of Changes |
Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health; Hungary: National Institute of Pharmacy; Bulgaria: Bulgarian Drug Agency; Romania: National Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
asthma treatment placebo efficacy safety |
Signs and Symptoms Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |