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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

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.

  • MDCNB-01
  • NanoCelle® d9-THC & CBD

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.

  • OxyNorm®
  • OxyContin®
  • Endone®
  • Proladone®
  • Targin®
    Significant changes in responders with NanaBis™ spray over placebo (p<0.05) [ Time Frame: 6 weeks ]
    Significant change in the Health-Related Quality of Life Scores Form (36) Health Survey (SF-36) with NanaBis™ spray over placebo (p<0.05) and comparable to Oxycodone CR [ 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 Scores Form (36) Health Survey (SF-36) for the NanaBis™ group are significantly changed than in the Placebo group and is similar to the Oxycodone group.

Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period [Time Frame: Baseline; End of Week 3 (3 weeks)]; and at End of Treatment Period [Time Frame: Baseline; End of Week 6 (3 weeks)]; and at End of Compassionate Period [Time Frame: Baseline; End of Week 18 (12 weeks)]

The Scores Form 36 (SF-36) includes 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant scores. Higher scores indicate improvement in health. Domain scale scores 0 (negative health) to 100 (positive health). 100 represents the best health state.

painDETECT Assessment at Baseline [Time Frame: Baseline]. painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component.

painDETECT Assessment for Participants at End of Titration and Optimal Dose Period [Time Frame: End of Week 1 to 3]; painDETECT Assessment for Participants at End of the Treatment Period [Time Frame: End of Weeks 4 to 6]; painDETECT Assessment for Participants at End of the Compassionate Period [Time Frame: End of Weeks 7 to 18].

painDETECT is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being "negative" (no neuropathic pain component). Value between 19 and 38 as being "positive" (presence of neuropathic component)". Values from 13 to 18 are scored as being "unclear".

To demonstrate that at the end of the 6-week study period that NanaBis™ is safe and tolerable. The daily use of NanaBis™ oro-buccal spray reduces the severity of Treatment-Emergent Adverse Events (safety and tolerability). [Time Frame: Change from Baseline and Titration and Treatment in UKU-Side Effects Rating Scale for Patients (UKU-SERS-Pat) at Weeks 1 to 3 and 4 to 6.]

Does the daily use of NanaBis™ oro-buccal spray reduce the severity of Treatment-Emergent Adverse Events (safety and tolerability). [Time Frame: Change during Compassionate Use in UKU-SERS-Pat at Weeks 7 to 18.]

Changes in validated UKU-SERS-Pat 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.