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Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

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.
 
ClinicalTrials.gov Identifier: NCT01057927
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : January 28, 2010
Sponsor:
Information provided by:
Oxagen Ltd

Tracking Information
First Submitted Date  ICMJE January 25, 2010
First Posted Date  ICMJE January 28, 2010
Last Update Posted Date January 28, 2010
Study Start Date  ICMJE January 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2010)
Forced expiratory volume in one second (FEV1) [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2010)
  • Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S)) [ Time Frame: 28 days ]
  • Sputum eosinophilia (subset of patients) and serum IgE [ Time Frame: 28 days ]
  • Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
Official Title  ICMJE Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
Brief Summary The purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic control.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: OC000459
    OC000459 capsules 2x100mg BID for 28 days
  • Drug: Placebo
    Placebo capsules to match OC000459 100mg capsules, 2 tablets BID
Study Arms  ICMJE
  • Experimental: OC000459
    Intervention: Drug: OC000459
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2010)
132
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria At Screening:

  • Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
  • 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:

  • Use of inhaled or local corticosteroids in the period from 28 days prior to screening.
  • Receipt of prescribed or over the counter medication within 14 days of the first study day.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057927
Other Study ID Numbers  ICMJE OC000459/006/06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr C Mike Perkins, Oxagen Ltd
Study Sponsor  ICMJE Oxagen Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oxagen Ltd
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP