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

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-centre, long term, double blind, clinical protocol for NanaBis™ as a monotherapy treatment in participants 18-70 years of age with cancer related pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medlab Clinical
• Collaborators: George Clinical Pty Ltd; WriteSource Medical Pty Ltd
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

At Screening Phase

Participants must fulfil all of the following criteria:

• Prospective male and female participants in the age range 18-70 years

• Metastatic bone pain from a cancer diagnosis is the only major cause of pain. Markers of disease progression (e.g. tenderness or unrelieved pain with changes in posture) may need to be randomised

• Pathology (blood, imaging) confirmed metastatic bone cancer

• Meet International Classification of Diseases-10 (ICD-10) codes for pain management criteria (i.e., bone cancer pain)

• During the screening period, the participant is on stable opioid pain management and pain severity (NPRS) ≤ 8 with a maximum variation of ± 1

• Pain Detect score > 18

• Participant willing and able to provide informed consent and follow study procedures

1. including agreeing to not drive or operate heavy machinery; and

2. females of child-bearing potential agree to use reliable contraception during the duration of the clinical trial

Exclusion Criteria:

At Screening Phase

Participants will be excluded if they meet any of the following criteria that include:

• History of epilepsy or recurrent seizures

• Moderate to severe medical conditions such as

1. severe hepatic;

2. cardiovascular or renal impairment; or

3. psychiatric disorders (i.e., unstable schizophrenia, recent drug-induced psychosis, severe mood disorders), that would be assessed at the medical screen

• Presence of substance abuse disorder such as nicotine or alcohol, or other illicit or prescription drug dependence (e.g., opioid dependence), or methadone or buprenorphine treatment for opioid dependence

• Women who are pregnant, lactating or planning to become pregnant

• Identified concerns by the nursing / medical team relevant to the safe storage of medications (i.e., NanaBis™ or standard medical therapy)

• Participant may not be available for follow up (i.e., planned or expected travel or other)