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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
Gender
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.
Address [1] 997 0
x
Country [1] 997 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cypress Bioscience, Inc
Address
Country
United States of America
Secondary sponsor category [1] 858 0
None
Name [1] 858 0
N/A
Address [1] 858 0
x
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
Trial related presentations / publications
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
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary