anaBis™ an Oro-Buccal Administered Equimolar d9-THC and CBD Formulation As Monotherapy For The Management of Opioid-Requiring Chronic-Pain Due To Metastatic Cancer: A Phase 3 Multi-Centre, Double Blind, Randomized-Withdrawal Active And Placebo Controlled Clinical Study

Medlab Clinical Ltd0 个研究点目标入组 360 人开始时间: 2021年9月27日最近更新: 2022年9月5日

适应症

试验速览

暂无简介。

•At Screening Phase participants must fulfill all of the following criteria:
•i.Prospective male and female participants that are
•a.in the age range 18 to 65 years or
•b.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)
•ii.Metastatic bone pain from a cancer diagnosis is the only major cause of pain.
•iii.Pathology (imaging) confirmed metastatic bone cancer;
•iv.Meet International Classification of Diseases, Tenth Revision (ICD-10) codes for pain management criteria (i.e., bone cancer pain);
•v.During the screening period, the participant is on stable opioid pain management and pain severity (NPRS) is less than or equal to 8 with a maximum variation of plus or minus 1.
•vi.Pain Detect score is greater than 18
•vii.Participant willing and able to provide informed consent and follow study procedures
•a.including agreeing to not drive or operate heavy machinery; and
•b.females of child-bearing potential agree to use reliable contraception during the duration of the clinical trial;
•viii.Patient deemed tolerable to Oxycodone and NanaBis™ determined by medical history of allergies to cannabinoids or opioids

•i.History of epilepsy or recurrent seizures;
•ii.Moderate to severe medical conditions such as
•a.Severe hepatic, cardiovascular, pulmonary or renal impairment; or
•b.Psychiatric disorders (i.e., unstable schizophrenia, recent drug-induced psychosis, severe mood disorders), that would be assessed at the medical screen;
•iii.If patients have been diagnosed with a substance abuse disorder.
•iv.Women who are pregnant, lactating or planning to become pregnant;
•v.Identified concerns by the nursing / medical team relevant to the safe storage of medications (i.e., NanaBis™ or standard medical therapy);
•vi.Participants who may not be available for follow up (i.e., planned or expected travel or other);
•vii.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;
•viii.Participants who are unable to withhold all analgesia (apart from that which is part of this trial) during the titration and maintenance phase of the study, including bisphosphonates. Medications such as bisphosphonates may be coordinated so they are given either side of the excluded period that covers the titration and maintenance phases

发起方