An initial factorial evaluation of the potential synergy between two novel agents (CB0011 and CB0012) for the treatment of Obstructive Sleep Apnea Syndrome

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000689673

Acronym

POC003

Enrollment

100

Registered

2005-10-24

Start date

2006-09-03

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

21 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

No exclusion criteria

Outcome results