Cancer Related PainPhase 3NCT04808531
NanaBis™ an Oro-buccal Administered delta9-Tetrahydrocannabinol (d9-THC) & Cannabidiol (CBD) Medicine for the Management of Bone Pain From Metastatic Cancers
A Phase 3 study testing NanaBis™, Oxycodone CR and Oxycodone IR in people with Cancer Related Pain, run by Medlab Clinical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Related Pain
- What is being tested?
- NanaBis™, Oxycodone CR and Oxycodone IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 65 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.
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- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: NanaBis™ an Oro-buccal Administered Equimolar d9-THC & CBD Formulation as Monotherapy for Management of Opioid Requiring Bone Pain Due to Metastatic Cancer: Phase 3 Multi Centre Blinded Randomized Withdrawal Active & Placebo Controlled Trial
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.
Read the detailed description
This trial uses an alternative method to demonstrate the analgesic efficacy of NanaBis™ as a monotherapy in cancer participants. Proving analgesic efficacy requires demonstrating that (i) the analgesic is significantly better than placebo and (ii) that the magnitude of the improvement is clinically important. The latter is standardly done by measuring the change in pain levels from a baseline (no analgesia) to the end of a treatment period. A 30% decrease in the Numerical Pain Rating Scale (NPRS) has been correlated with participants reporting a moderate improvement in their pain and this was adopted as the standard method of demonstrating a clinically important magnitude of improvement. In this strategy, the measure of analgesic efficacy is the proportion of participants in the treatment group whose pain is adequately treated (responders). A responder is defined as a patient who completes the treatment phase with an acceptable level of pain (NPRS ≤ 5) and without requiring excessive amounts of rescue (breakthrough analgesia) medication. Unlimited breakthrough analgesia (Oxycodone) is allowed throughout the study; however, excessive use will result in discontinuation. Comparison of the proportion of responders in the NanaBis™ arm and placebo arms will determine if NanaBis™ is significantly better than placebo. Demonstrating that the proportion of responders in the NanaBis™ arm is non-inferior to the Oxycodone controlled release (CR) comparator arm will determine if the magnitude of improvement (provided by NanaBis™) is clinically important because Oxycodone CR has been established as the benchmark analgesic that provides a clinically important effect.
- Conditions
- Cancer Related Pain
- Being tested
- NanaBis™, Oxycodone CR, Placebo Spray, Placebo Tablet, Oxycodone IR
- Keywords
- Cannabis based medicine, d9-tetrahydrocannabinol, Cannabidiol, Cancer Pain, Cancer Bone Pain, Treatment, Monotherapy, Nanoparticle, Tetrahydrocannabinol
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanaBis™Drug
Also called MDCNB-01, NanoCelle® d9-THC & CBD
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
Oxycodone CRDrug
Also called OxyNorm®, OxyContin®, Endone®, Proladone®
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.
Placebo SprayDrug
Also called NanoCelle® Placebo Spray
Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.
Placebo TabletDrug
Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.
Oxycodone IRDrug
Also called Oxyfast®, Oxy IR®, Oxaydo®, Roxicodone®
Oxycodone immediate release (IR) tablet or capsule or oral solution used as breakthrough analgesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Oxycodone CR; Drug: Placebo Spray; Drug: Oxycodone IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (5)
Comparable efficacy in proportion of responders from NanaBis™ spray to the proportion of responders to Oxycodone CR
To demonstrate that at the end of the 6-week study period the proportion of responders in the NanaBis™ group is similar to the proportion of responders in the Oxycodone group determined by pain levels recorded using NPRS.
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.
Measured: 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
To demonstrate that at the end of the 6-week study period the Health-Related Quality of Life scores in the NanaBis™ treated group are significantly changed than in the Placebo group and is similar to the Oxycodone CR treated group.
Quality of life as assessed by the EORTC-QLQ-C30 validated questionnaire [ Time Frame: Baseline and then weekly during the maintenance phase of the study and at then weeks 7 and 18 of the Open Label Extension].
The EORTC-QLQ-C30 is validated questionnaire answered by participants to assess the quality of life of cancer patients. It assesses important functioning domains (e.g. physical, emotional, role) and common cancer symptoms (e.g. fatigue, pain, nausea/vomiting, appetite loss).
Measured: 6 weeks
Significant change in the NPRS score with NanaBis™ spray over placebo (p<0.05) and comparable to Oxycodone CR
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.
Measured: 18 weeks
NanaBis™ Adverse Events
To demonstrate that at the end of the 6-week study period that NanaBis™ is safe and tolerable.
Safety and tolerability will be assessed via standardised adverse events, Serious adverse events, Deaths, UKU - Side Effects Rating Scale (UKU), Local Adverse Events Charts and patient medical records.
Adverse events, serious adverse events and deaths will be summarised by treatment arm.
Does the daily use of NanaBis™ oro-buccal spray reduce the severity of Treatment-Emergent Adverse Events (safety and tolerability). [Time Frame: Baseline and then weekly for the duration of the study].
Changes in validated UKU scale range is 0 to 3 for rating the degree of severity (mild, moderate or severe) and a second scale for the investigator that assigns a casual relationship of improbable, possible or probable.
Measured: 18 weeks
Fifty percent or greater of the NanaBis™ treated group request compassionate extension with NanaBis™ spray
To demonstrate that at the end of the 6-week study period that after unblinding, half or more of the NanaBis™ treated group prefer further treatment with NanaBis™ in the open label extension phase (note that all participants will be all offered open label extension if appropriate).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study startNov 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Cancer Related PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medlab Clinical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emerald Clinical Inc., WriteSource Medical Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808531
- Sponsor's protocol ID
- MDC-NB-P3-01
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
PubMed 11690728Kress HG, Koch ED, Kosturski H, Steup A, Karcher K, Lange B, Dogan C, Etropolski MS, Eerdekens M. Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain. Pain Physician. 2014 Jul-Aug;17(4):329-43.
PubMed 25054392Anderson W. 2007 National Statement on Ethical Conduct in Human Research. Intern Med J. 2011 Jul;41(7):581-2. doi: 10.1111/j.1445-5994.2011.02528.x. No abstract available.
PubMed 21762341Portenoy RK. Treatment of cancer pain. Lancet. 2011 Jun 25;377(9784):2236-47. doi: 10.1016/S0140-6736(11)60236-5.
PubMed 21704873Deandrea S, Montanari M, Moja L, Apolone G. Prevalence of undertreatment in cancer pain. A review of published literature. Ann Oncol. 2008 Dec;19(12):1985-91. doi: 10.1093/annonc/mdn419. Epub 2008 Jul 15.
PubMed 18632721Wiffen PJ, McQuay HJ. Oral morphine for cancer pain. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003868. doi: 10.1002/14651858.CD003868.pub2.
PubMed 17943804Kane CM, Hoskin P, Bennett MI. Cancer induced bone pain. BMJ. 2015 Jan 29;350:h315. doi: 10.1136/bmj.h315. No abstract available.
PubMed 25633978Gregorian RS Jr, Gasik A, Kwong WJ, Voeller S, Kavanagh S. Importance of side effects in opioid treatment: a trade-off analysis with patients and physicians. J Pain. 2010 Nov;11(11):1095-108. doi: 10.1016/j.jpain.2010.02.007. Epub 2010 May 10.
PubMed 20452835Macedo F, Ladeira K, Pinho F, Saraiva N, Bonito N, Pinto L, Goncalves F. Bone Metastases: An Overview. Oncol Rev. 2017 May 9;11(1):321. doi: 10.4081/oncol.2017.321. eCollection 2017 Mar 3.
PubMed 28584570Choong PF. The molecular basis of skeletal metastases. Clin Orthop Relat Res. 2003 Oct;(415 Suppl):S19-31. doi: 10.1097/01.blo.0000093839.72468.da.
PubMed 14600589Pezaro C, Omlin A, Lorente D, Rodrigues DN, Ferraldeschi R, Bianchini D, Mukherji D, Riisnaes R, Altavilla A, Crespo M, Tunariu N, de Bono J, Attard G. Visceral disease in castration-resistant prostate cancer. Eur Urol. 2014 Feb;65(2):270-273. doi: 10.1016/j.eururo.2013.10.055. Epub 2013 Nov 22.
PubMed 24295792Bubendorf L, Schopfer A, Wagner U, Sauter G, Moch H, Willi N, Gasser TC, Mihatsch MJ. Metastatic patterns of prostate cancer: an autopsy study of 1,589 patients. Hum Pathol. 2000 May;31(5):578-83. doi: 10.1053/hp.2000.6698.
PubMed 10836297Yanae M, Fujimoto S, Tane K, Tanioka M, Fujiwara K, Tsubaki M, Yamazoe Y, Morishima Y, Chiba Y, Takao S, Komoike Y, Tsurutani J, Nakagawa K, Nishida S. Increased risk of SSEs in bone-only metastatic breast cancer patients treated with zoledronic acid. J Bone Oncol. 2017 Aug 31;8:18-22. doi: 10.1016/j.jbo.2017.08.004. eCollection 2017 Sep.
PubMed 28884071Body JJ, Quinn G, Talbot S, Booth E, Demonty G, Taylor A, Amelio J. Systematic review and meta-analysis on the proportion of patients with breast cancer who develop bone metastases. Crit Rev Oncol Hematol. 2017 Jul;115:67-80. doi: 10.1016/j.critrevonc.2017.04.008. Epub 2017 Apr 23.
PubMed 28602171Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6243s-6249s. doi: 10.1158/1078-0432.CCR-06-0931.
PubMed 17062708
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NanaBis™ an Oro-buccal Administered Equimolar d9-THC & CBD Formulation as Monotherapy for Management of Opioid Requiring Bone Pain Due to Metastatic Cancer: Phase 3 Multi Centre Blinded Randomized Withdrawal Active & Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04808531
- Acronym / sponsor ID
- MDC-NB-P3-01
- Conditions
- Cancer Related Pain
- Keywords
- Cannabis based medicine, d9-tetrahydrocannabinol, Cannabidiol, Cancer Pain, Cancer Bone Pain, Treatment, Monotherapy, Nanoparticle
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Medlab ClinicalIndustry (pharma, biotech, devices)
- Collaborators
- Emerald Clinical Inc., WriteSource Medical Pty Ltd
- Study start
- Nov 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial uses an alternative method to demonstrate the analgesic efficacy of NanaBis™ as a monotherapy in cancer participants. Proving analgesic efficacy requires demonstrating that (i) the analgesic is significantly better than placebo and (ii) that the magnitude of the improvement is clinically important. The latter is standardly done by measuring the change in pain levels from a baseline (no analgesia) to the end of a treatment period. A 30% decrease in the Numerical Pain Rating Scale (NPRS) has been correlated with participants reporting a moderate improvement in their pain and this was adopted as the standard method of demonstrating a clinically important magnitude of improvement. In this strategy, the measure of analgesic efficacy is the proportion of participants in the treatment group whose pain is adequately treated (responders). A responder is defined as a patient who completes the treatment phase with an acceptable level of pain (NPRS ≤ 5) and without requiring excessive amounts of rescue (breakthrough analgesia) medication. Unlimited breakthrough analgesia (Oxycodone) is allowed throughout the study; however, excessive use will result in discontinuation. Comparison of the proportion of responders in the NanaBis™ arm and placebo arms will determine if NanaBis™ is significantly better than placebo. Demonstrating that the proportion of responders in the NanaBis™ arm is non-inferior to the Oxycodone controlled release (CR) comparator arm will determine if the magnitude of improvement (provided by NanaBis™) is clinically important because Oxycodone CR has been established as the benchmark analgesic that provides a clinically important effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double Placebo Arm | Placebo comparator | Drug: Placebo Spray, Drug: Placebo Tablet, Drug: Oxycodone IRSpray 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. |
| Treatment NanaBis™ Arm | Experimental | Drug: NanaBis™, Drug: Placebo Tablet, Drug: Oxycodone IRNanaBis™ + 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. |
| Comparator (Oxycodone) Arm | Active comparator | Drug: Oxycodone CR, Drug: Placebo Spray, Drug: Oxycodone IRSpray 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- At Screening Phase
- Prospective male and female participants that are:
- 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)
Key exclusion criteria (14 listed)
- At Screening Phase
- History of epilepsy or recurrent seizures
- Moderate to severe medical conditions such as
- If participants have been diagnosed with a current substance abuse disorder
- Women who are pregnant, lactating or planning to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanaBis™Also: MDCNB-01, NanoCelle® d9-THC & CBDNanaBis™ 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 | Treatment NanaBis™ Arm |
| Oxycodone CRAlso: OxyNorm®, OxyContin®, Endone®, Proladone®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 | Comparator (Oxycodone) Arm |
| Placebo SprayAlso: NanoCelle® Placebo SprayPlacebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms. | Drug | Comparator (Oxycodone) Arm, Double Placebo Arm |
| Placebo TabletPlacebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms. | Drug | Double Placebo Arm, Treatment NanaBis™ Arm |
| Oxycodone IRAlso: Oxyfast®, Oxy IR®, Oxaydo®, Roxicodone®Oxycodone immediate release (IR) tablet or capsule or oral solution used as breakthrough analgesia. | Drug | Comparator (Oxycodone) Arm, Double Placebo Arm, Treatment NanaBis™ Arm |
Primary outcome
Significant changes in responders with NanaBis™ spray over placebo (p<0.05)
Time frame: 6 weeks
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.
5 secondary outcomes
Comparable efficacy in proportion of responders from NanaBis™ spray to the proportion of responders to Oxycodone CR
Time frame: 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
Time frame: 6 weeks
Significant change in the NPRS score with NanaBis™ spray over placebo (p<0.05) and comparable to Oxycodone CR
Time frame: 18 weeks
NanaBis™ Adverse Events
Time frame: 18 weeks
Fifty percent or greater of the NanaBis™ treated group request compassionate extension with NanaBis™ spray
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Background: PubMed 11690728Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
- Background: PubMed 25054392Kress HG, Koch ED, Kosturski H, Steup A, Karcher K, Lange B, Dogan C, Etropolski MS, Eerdekens M. Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain. Pain Physician. 2014 Jul-Aug;17(4):329-43.
- Background: PubMed 21762341Anderson W. 2007 National Statement on Ethical Conduct in Human Research. Intern Med J. 2011 Jul;41(7):581-2. doi: 10.1111/j.1445-5994.2011.02528.x. No abstract available.
- Background: PubMed 21704873Portenoy RK. Treatment of cancer pain. Lancet. 2011 Jun 25;377(9784):2236-47. doi: 10.1016/S0140-6736(11)60236-5.
- Background: PubMed 18632721Deandrea S, Montanari M, Moja L, Apolone G. Prevalence of undertreatment in cancer pain. A review of published literature. Ann Oncol. 2008 Dec;19(12):1985-91. doi: 10.1093/annonc/mdn419. Epub 2008 Jul 15.
- Background: PubMed 17943804Wiffen PJ, McQuay HJ. Oral morphine for cancer pain. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003868. doi: 10.1002/14651858.CD003868.pub2.
- Background: PubMed 25633978Kane CM, Hoskin P, Bennett MI. Cancer induced bone pain. BMJ. 2015 Jan 29;350:h315. doi: 10.1136/bmj.h315. No abstract available.
- Background: PubMed 20452835Gregorian RS Jr, Gasik A, Kwong WJ, Voeller S, Kavanagh S. Importance of side effects in opioid treatment: a trade-off analysis with patients and physicians. J Pain. 2010 Nov;11(11):1095-108. doi: 10.1016/j.jpain.2010.02.007. Epub 2010 May 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NanaBis™, Oxycodone CR and Oxycodone IR in people with Cancer Related Pain, run by Medlab Clinical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof. Luis Vitetta (+61 8188 0311 ext. 106, luis_vitetta@medlab.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant changes in responders with NanaBis™ spray over placebo (p<0.05) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04808531, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.