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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2022-04-12
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
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
MDCNB-01 · NanoCelle® d9-THC & CBDOxycodone 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.
OxyNorm® · OxyContin® · Endone® · Proladone® · Targin® · Xtampza ER®Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.
NanoCelle® Placebo SprayPlacebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.
Oxycodone immediate release (IR) tablet or capsule or oral solution used as breakthrough analgesia.
Oxyfast® · Oxy IR® · Oxaydo® · Roxicodone®Eligibility
primary outcomes
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.
secondary outcomes
Time frame: 6 weeks
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.
Time frame: 6 weeks
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).
Time frame: 18 weeks
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.
Publications
No exact PMID-linked public article is currently readable locally.
Time frame: 18 weeks
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.
Time frame: 12 weeks
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).