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Trial registered on ANZCTR


Registration number
ACTRN12605000687695
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
24/10/2005
Date last updated
11/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A proof of concept, single centre, monotherapy, dose-ranging trial to evaluate the efficacy and tolerability of CB0011 at 0,7.5, 15, 30 and 45mg in Obstructive Sleep Apnea.
Scientific title
A proof of concept, single centre, monotherapy, dose-ranging trial to evaluate the efficacy and tolerability of CB0011 at 0,7.5, 15, 30 and 45mg in Obstructive Sleep Apnea.
Universal Trial Number (UTN)
Trial acronym
POC001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 835 0
Condition category
Condition code
Respiratory 903 903 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A six week cross-over design study in patients with Obstructive Sleep Apnea (OSA). Patients (n=42) will be randomly enrolled into one of six dose sequence groups at an equivalent ratio.
Intervention code [1] 502 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1169 0
Changes in Obstructive Sleep Apnea as measured by the patient apnea hypopnea index score (AHI).
Timepoint [1] 1169 0
Parameters measured at baseline, week two, week four and week six (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] 1170 0
Changes in Obstructive Sleep Apnea as measured by the respiratory disturbance index (RDI).
Timepoint [2] 1170 0
Parameters measured at baseline, week two, week four and week six (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] 1171 0
Changes in Obstructive Sleep Apnea as measured by oxygen desaturation index (ODI).
Timepoint [3] 1171 0
Parameters measured at baseline, week two, week four and week six (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] 2149 0
Changes in daytime sedation, sleep quality, mood, fatigue and weight.
Timepoint [1] 2149 0
Measured at baseline, week two, week four and week six.
Secondary outcome [2] 2150 0
Early termination and quality of life.
Timepoint [2] 2150 0
Measured at baseline and week six 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 40 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 to dose sequence and customised computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/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] 996 0
Commercial sector/Industry
Name [1] 996 0
Cypress Biosince Inc.
Address [1] 996 0
x
Country [1] 996 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Cypress Bioscience Inc
Address
Country
United States of America
Secondary sponsor category [1] 857 0
None
Name [1] 857 0
N/A
Address [1] 857 0
x
Country [1] 857 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2302 0
Woolcock Institute of Medical Research
Ethics committee address [1] 2302 0
Ethics committee country [1] 2302 0
Australia
Date submitted for ethics approval [1] 2302 0
Approval date [1] 2302 0
Ethics approval number [1] 2302 0
Ethics committee name [2] 2303 0
Royal Prince Alfred Hospital
Ethics committee address [2] 2303 0
Ethics committee country [2] 2303 0
Australia
Date submitted for ethics approval [2] 2303 0
Approval date [2] 2303 0
Ethics approval number [2] 2303 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35172 0
Address 35172 0
Country 35172 0
Phone 35172 0
Fax 35172 0
Email 35172 0
Contact person for public queries
Name 9691 0
Renee Crompton
Address 9691 0
Sleep and Circadian Research Group
Woolcock Institute of Medical Research
Royal Prince Alfred Hospital
Page 7
Missenden Road
Camperdown NSW 2050
Country 9691 0
Australia
Phone 9691 0
+61 2 95157763
Fax 9691 0
+61 2 95575059
Email 9691 0
reneec@woolcock.org.au
Contact person for scientific queries
Name 619 0
Associate Professor Ron Grunstein
Address 619 0
Sleep and Circadian Research Group
Woolcock Institute of Medical Research
Level 6 Building F
88 Mallett Street
Camperdown NSW 2050
Country 619 0
Australia
Phone 619 0
+61 2 95158630
Fax 619 0
+61 2 95157196
Email 619 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