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

NCT04808531 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-04-12

No results posted yet for this study

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

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 & Collaborators

  • Emerald Clinical Inc.

    collaborator INDUSTRY

  • WriteSource Medical Pty Ltd

    collaborator UNKNOWN

  • Medlab Clinical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-02-29
Completion
2024-06-30
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04808531 on ClinicalTrials.gov