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OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma

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: NCT00890877
Recruitment Status : Completed
First Posted : April 30, 2009
Last Update Posted : September 2, 2010
Sponsor:
Information provided by:
Oxagen Ltd

Tracking Information
First Submitted Date  ICMJE April 29, 2009
First Posted Date  ICMJE April 30, 2009
Last Update Posted Date September 2, 2010
Study Start Date  ICMJE April 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2009)
Forced expiratory volume in one second (FEV1) [ Time Frame: 17 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2009)
Asthma quality of life questionnaire (AQLQ) [ Time Frame: 17 weeks ]
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 OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mild to Moderate Persistent Asthma
Intervention  ICMJE Drug: OC000459 or placebo
Pills, active and/or placebo given twice daily for 17 weeks
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: OC000459 or placebo
  • Experimental: 2
    Intervention: Drug: OC000459 or placebo
  • Experimental: 3
    Intervention: Drug: OC000459 or placebo
  • Experimental: 4
    Intervention: Drug: OC000459 or placebo
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: April 29, 2009)
480
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
  • Aged 18 to 55 years inclusive.
  • Non smokers for at least the past 12 months with a pack history of less than 10 pack years.
  • Mild to moderate persistent asthma according to GINA4 guidelines for at least 12 months

Exclusion criteria:

  • Receipt of prescribed or over the counter medication within 14 days prior to 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 Bulgaria,   Hungary,   Poland,   Romania,   Russian Federation,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00890877
Other Study ID Numbers  ICMJE OC000459/012/08
Has Data Monitoring Committee No
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 September 2010

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