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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000688684

Acronym

POC002

Enrollment

100

Registered

2005-10-24

Start date

2005-06-09

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 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.

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, 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.

Exclusion criteria

No exclusion criteria

Outcome results