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

NCT04808531 | Unknown Phase 3 FDA Drug

• 1 other identifier: MDC-NB-P3-01
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-centre, long term, double blind, clinical protocol for NanaBis™ as a monotherapy treatment in participants 18-75 years of age with cancer related pain.

Conditions

Cancer Related Pain

Keywords

Cannabis based medicine; d9-tetrahydrocannabinol; Cannabidiol; Cancer Pain; Cancer Bone Pain; Treatment; Monotherapy; Nanoparticle; Tetrahydrocannabinol

Outcome Measures

Primary Outcomes (1)

• Significant changes in responders with NanaBis™ spray over placebo (p<0.05)

  To demonstrate that at the end of the 6-week study period the proportion of responders in the NanaBis™ group shows significant change than the proportion of responders in the placebo group. A responder is defined as a participant who completes the maintenance phase with an acceptable level of pain (NPRS is equal to 5) and without requiring excessive amounts of rescue (breakthrough analgesia) medication. NPRS Assessment \[Time Frame: Baseline and then twice daily for the duration of the study\]. The NPRS questionnaire is completed by the participant to determine their pain intensity. The NPRS is an 11-point scale scored from '0-10'. A score of '0' being no pain and a score of '10' being the most intense pain imaginable. Participants select the value that is most in line with the intensity of pain they have experienced in the last 24 hours.

  6 weeks

Secondary Outcomes (5)

• Comparable efficacy in proportion of responders from NanaBis™ spray to the proportion of responders to Oxycodone CR

  6 weeks

• Significant change in the Health-Related Quality of Life Scores with NanaBis™ spray over placebo (p<0.05) and comparable to Oxycodone CR

  6 weeks

• Significant change in the NPRS score with NanaBis™ spray over placebo (p<0.05) and comparable to Oxycodone CR

  18 weeks

• NanaBis™ Adverse Events

  18 weeks

• Fifty percent or greater of the NanaBis™ treated group request compassionate extension with NanaBis™ spray

  12 weeks

Study Arms (3)

Double Placebo Arm

PLACEBO COMPARATOR

Spray Placebo + Tablet Placebo Spray Placebo is a nanoparticle water soluble solution without cannabinoids containing a small amount of hemp seed oil (for fragrance purposes only) as defined by Australian Office of Drug Control (ODC) (https://www.odc.gov.au/hemp-products). One dose is equivalent to 2 actuations of the pump delivering 280 µL volume. Tablet Placebo will be identical to the Oxycontin tablets.

Drug: Placebo Spray; Drug: Placebo Tablet; Drug: Oxycodone IR

Treatment NanaBis™ Arm

EXPERIMENTAL

NanaBis™ + Tablet Placebo NanaBis™ is a nanoparticle water soluble equimolar solution of d9-THC and 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. The dose administered will be 1 - 3.5 doses (2 sprays to 7 sprays) per 4 hours unless asleep.

Drug: NanaBis™; Drug: Placebo Tablet; Drug: Oxycodone IR

Comparator (Oxycodone) Arm

ACTIVE COMPARATOR

Spray Placebo + Oxycodone CR Spray Placebo is a nanoparticle water soluble solution without cannabinoids containing a small amount of hemp seed oil (for fragrance purposes only) as defined by Australian ODC (https://www.odc.gov.au/hemp-products). One dose is equivalent to 2 actuations of the pump delivering 280 µL volume. Oxycodone controlled release (CR) used as a comparator will be Oxycontin tablets 10 mg - 70 mg po bd.

Drug: Oxycodone CR; Drug: Placebo Spray; Drug: Oxycodone IR

Interventions

NanaBis™ DRUG

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

Also known as: MDCNB-01, NanoCelle® d9-THC & CBD

Treatment NanaBis™ Arm

Oxycodone CR DRUG

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.

Also known as: OxyNorm®, OxyContin®, Endone®, Proladone®, Targin®, Xtampza ER®

Comparator (Oxycodone) Arm

Placebo Spray DRUG

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

Also known as: NanoCelle® Placebo Spray

Comparator (Oxycodone) Arm; Double Placebo Arm

Placebo Tablet DRUG

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

Double Placebo Arm; Treatment NanaBis™ Arm

Oxycodone IR DRUG

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

Also known as: Oxyfast®, Oxy IR®, Oxaydo®, Roxicodone®

Comparator (Oxycodone) Arm; Double Placebo Arm; Treatment NanaBis™ Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At Screening Phase
• Participants must fulfil all of the following criteria:
• Prospective male and female participants that are:
• in the age range 18-65 years or
• to 75 years without significant co-morbidities (heart, lung, liver or renal failure, myocardial infarction, cerebral vascular accident, peripheral vascular disease, chronic obstructive pulmonary disease, dementia, connective tissue disease or diabetes mellitus with end-organ damage)
• Metastatic bone pain from a cancer diagnosis is the only major cause of pain.
• Documented proof (imaging) confirming the Metastatic Bone Disease at the current site of pain and that there has no been treatment since diagnosis
• Meet International Classification of Diseases, Tenth Revision (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
• including agreeing to not drive or operate heavy machinery; and
• females of child-bearing potential agree to use reliable contraception during the duration of the clinical trial
• Patient deemed tolerable to Oxycodone and NanaBis™ determined by medical history of allergies to cannabinoids or opioids
• Patient must not be a participant in a clinical trial or study.

You may not qualify if:

• 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
• Severe hepatic, cardiovascular, pulmonary or renal impairment or
• Psychiatric disorders (i.e., unstable schizophrenia, recent drug-induced psychosis, severe mood disorders), that would be assessed at the medical screen
• If participants have been diagnosed with a current substance abuse disorder
• 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)
• Participants who may not be available for follow up (i.e., planned or expected travel or other)
• Participants plan to undergo any treatment that will substantially reduce the burden of disease (and therefore bone pain) during the screening, titration or maintenance phase of the clinical trial such as radiotherapy or cytotoxic chemotherapy
• Participants who are unable to withhold all analgesia (apart from which is part of this trial) during the titration and maintenance phase of the study, including bisphosphonates, or are currently exceeding equivalence of 70mg BD Oxycodone CR. Medications such as bisphosphonates may be coordinated so they are given either side of the excluded period that covers the titration and maintenance phases
• Participants will NOT be excluded if they are being treated with maintenance pharmacotherapy to prevent progression of disease such as steroids and hormone therapy, which may be continued during the trial at a stable dose
• Participant will be excluded if they are participating in any other clinical trial or study.

Sponsors & Collaborators

• Medlab Clinical: lead
• Emerald Clinical Inc.: collaborator
• WriteSource Medical Pty Ltd: collaborator

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Related Links

• Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95). Annotated with TGA comments,. 2001.
• VA Evidence-based Synthesis Program Reports. In Benefits and Harms of Cannabis in Chronic Pain or Post-traumatic Stress Disorder: A Systematic Review, Department of Veterans Affairs (US): Washington (DC), 2017.

MeSH Terms

Conditions

Cancer Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Prof. Luis Vitetta

CONTACT

+61 8188 0311; luis_vitetta@medlab.co

Dr. Michael Lyon

CONTACT

+1 604 777 5500; doctorlyon@me.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 22, 2021
• Study Start: November 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 12, 2022

Record last verified: 2022-04