Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000689673
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
24/10/2005
Date last updated
24/10/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
An initial factorial evaluation of the potential synergy between two novel agents (CB0011 and CB0012) for the treatment of Obstructive Sleep Apnea Syndrome
Scientific title
An initial factorial evaluation of the potential synergy between two novel agents (CB0011 and CB0012) for the treatment of Obstructive Sleep Apnea Syndrome
Universal Trial Number (UTN)
Trial acronym
POC003
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea Syndrome 837 0
Condition category
Condition code
Respiratory 905 905 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A four week 1:1:1:1:1 randomised study in patients with diagnosed Obstructive Sleep Apnea Syndrome. 100 completed patients, 20 to be randomised to CB0012 alone at two different sequential doses, 20 patients to be randomised to 15mg of CB0011 and CB0012 at two different sequential doses, 20 patients to be randomised to 30mg of CB0011 and CB0012 at two different sequential doses, 20 patients to be randomised to CB0011 alone, and 20 patients to be randomised to placebo.
Intervention code [1] 510 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1175 0
Changes in Obstructive Sleep Apnea as measured by the patient apnea hypopnea index score (AHI).
Timepoint [1] 1175 0
Parameters measured at baseline, week two 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] 1176 0
Changes in Obstructive Sleep Apnea as measured by the respiratory disturbance index (RDI).
Timepoint [2] 1176 0
Parameters measured at baseline, week two 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] 1177 0
Changes in Obstructive Sleep Apnea as measured by oxygen desaturation index (ODI).
Timepoint [3] 1177 0
Parameters measured at baseline, week two 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] 2152 0
Changes in daytime sedation, quality of life, sleep quality, mood, fatigue and weight.
Timepoint [1] 2152 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 Syndrome, 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
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
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 998 0
Commercial sector/Industry
Name [1] 998 0
Cypress Biosince Inc.
Country [1] 998 0
Primary sponsor type
Commercial sector/Industry
Name
Cypress Bioscience, Inc
Address
Country
United States of America
Secondary sponsor category [1] 859 0
None
Name [1] 859 0
N/A
Address [1] 859 0
Country [1] 859 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36224 0
Address 36224 0
Country 36224 0
Phone 36224 0
Fax 36224 0
Email 36224 0
Contact person for public queries
Name 9699 0
Renee Crompton
Address 9699 0
Sleep and Circadian Research Group
Woolcock Institute of Medical Research
Royal Prince Alfred Hospital
Page 7
Missenden Road
Camperdown NSW 2050
Country 9699 0
Australia
Phone 9699 0
+61 2 95157763
Fax 9699 0
+61 2 95575059
Email 9699 0
reneec@woolcock.org.au
Contact person for scientific queries
Name 627 0
Associate Professor Ron Grunstein
Address 627 0
Sleep and Circadian Research Group
Woolcock Institute of Medical Research
Level 6 Building F
88 Mallett Street
Camperdown NSW 2050
Country 627 0
Australia
Phone 627 0
+61 2 95158630
Fax 627 0
+61 2 95157196
Email 627 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.