NanaBis™ an Oro-buccal Administered delta9-Tetrahydrocannabinol (d9-THC) & Cannabidiol (CBD) Medicine for the Management of Bone Pain From Metastatic Cancers

PHASE3UnknownINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

November 30, 2023

Primary Completion Date

February 29, 2024

Study Completion Date

June 30, 2024

Conditions
Cancer Related Pain
Interventions
DRUG

NanaBis™

NanaBis™ is a nanoparticle water soluble equimolar solution of d9-THC \& CBD. One dose is equivalent to 2 actuations of the pump delivering 280 µL volume containing 2.5 mg d9-THC and 2.5 mg CBD

DRUG

Oxycodone CR

Oxycodone CR tablet is an opioid agonist supplied in 10 mg, 15 mg, 20 mg, 30 mg,40 mg, 60 mg and 80 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt.

DRUG

Placebo Spray

Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.

DRUG

Placebo Tablet

Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.

DRUG

Oxycodone IR

Oxycodone immediate release (IR) tablet or capsule or oral solution used as breakthrough analgesia.

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Emerald Clinical Inc.

INDUSTRY

collaborator

WriteSource Medical Pty Ltd

UNKNOWN

lead

Medlab Clinical

INDUSTRY