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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000687695

Acronym

POC001

Enrollment

Registered

2005-10-24

Start date

2006-05-04

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

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 40 at the time of study entry.

Exclusion criteria

No exclusion criteria

Outcome results