Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000688684
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
24/10/2005
Date last updated
11/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A proof of concept, multi-centre evaluation of the potential beneficial effects of CB0011 when combined with CB0012 for the treatment of obstructive sleep apnea.
Scientific title
A proof of concept, multi-centre evaluation of the potential beneficial effects of CB0011 when combined with CB0012 for the treatment of obstructive sleep apnea.
Universal Trial Number (UTN)
Trial acronym
POC002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 836 0
Condition category
Condition code
Respiratory 904 904 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A four week 2:2:1 randomised study in patients diagnosed with obstructive sleep apnea. 100 completed patients required with 40 to be randomised to CB0011 alone, 40 patients to be randomised to CB0011 and CB0012 and 20 patients randomised to placebo.
Intervention code [1] 507 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1172 0
Changes in Obstructive Sleep Apnea as measured by the patient apnea hypopnea index score (AHI).
Timepoint [1] 1172 0
Parameters measured at baseline and week four (or early termination) by overnight polysomnography and between three and five nights per week by patients utilising an ambulatory home monitoring device.
Primary outcome [2] 1173 0
Changes in Obstructive Sleep Apnea as measured by the respiratory disturbance index (RDI).
Timepoint [2] 1173 0
Parameters measured at baseline and week four (or early termination) by overnight polysomnography and between three and five nights per week by patients utilising an ambulatory home monitoring device.
Primary outcome [3] 1174 0
Changes in Obstructive Sleep Apnea as measured by oxygen desaturation index (ODI).
Timepoint [3] 1174 0
Parameters measured at baseline and week four (or early termination) by overnight polysomnography and between three and five nights per week by patients utilising an ambulatory home monitoring device.
Secondary outcome [1] 2151 0
Changes in daytime sedation, quality of life, sleep quality, mood, fatigue and weight measured.
Timepoint [1] 2151 0
Measured at baseline, week two, and week four or early termination.

Eligibility
Key inclusion criteria
Subjects must have a current diagnosis of Obstructive Sleep Apnea, have an apnea-hypopnea index (AHI) of between 10-40 (using a strict definition of hypopnea), with a calculated BMI equal or less than 34 at the time of study entry.
Minimum age
21 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation at pharmacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block allocation and customised computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 997 0
Commercial sector/Industry
Name [1] 997 0
Cypress Biosince Inc.
Country [1] 997 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cypress Bioscience, Inc
Country
United States of America
Secondary sponsor category [1] 858 0
None
Name [1] 858 0
N/A
Country [1] 858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2304 0
Woolcock Institute of Medical Research
Ethics committee address [1] 2304 0
Ethics committee country [1] 2304 0
Australia
Date submitted for ethics approval [1] 2304 0
Approval date [1] 2304 0
Ethics approval number [1] 2304 0
Ethics committee name [2] 2305 0
Royal Prince Alfred Hospital
Ethics committee address [2] 2305 0
Ethics committee country [2] 2305 0
Australia
Date submitted for ethics approval [2] 2305 0
Approval date [2] 2305 0
Ethics approval number [2] 2305 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 35707 0
Address 35707 0
Country 35707 0
Phone 35707 0
Fax 35707 0
Email 35707 0
Contact person for public queries
Name 9696 0
Renee Crompton
Address 9696 0
Sleep and Circadian Research Group Woolcock Institute of Medical Research Royal Prince Alfred Hospital Page 7 Missenden Road Camperdown NSW 2050
Country 9696 0
Australia
Phone 9696 0
+61 2 95157763
Fax 9696 0
+61 2 95575059
Email 9696 0
reneec@woolcock.org.au
Contact person for scientific queries
Name 624 0
Associate Professor Ron Grunstein
Address 624 0
Sleep and Circadian Research Group Woolcock Institute of Medical Research Level 6 Building F 88 Mallett Street Camperdown NSW 2050
Country 624 0
Australia
Phone 624 0
+61 2 95158630
Fax 624 0
+61 2 95157196
Email 624 0
rrg@med.usyd.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.