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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12620000741987
Ethics application status
Approved
Date submitted
3/06/2020
Date registered
16/07/2020
Date last updated
1/12/2021
Date data sharing statement initially provided
16/07/2020
Date results information initially provided
1/12/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
An Open Label Observational Study of Safety and Efficacy of a Pharmaceutical grade Cannabis Medicine (MediCabilis™-CBD extract Oil) in Patients undergoing Medicinal Cannabis Therapy for Different Indications
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Scientific title
An Open Label, Multicenter, Observational Study to Assess the Safety, Tolerability and Efficacy of a Pharmaceutical grade Cannabis Medicine (MediCabilis™-CBD extract Oil) in Patients undergoing Medicinal Cannabis Therapy for Different Indications
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Secondary ID [1]
301436
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Bod Australia. Protocol number: BOD20201
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Universal Trial Number (UTN)
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Trial acronym
BODOLOS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Any approved condition for which MediCabilis has been prescribed for through either Special Access Scheme- Cat B or by an authorised prescriber
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Chronic pain
317729
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Seizure management/Epilepsy
317730
0
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Post-traumatic stress disorder
317731
0
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Neuropathic pain
317732
0
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Anxiety
317733
0
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Parkinson's disease/Tremor
317734
0
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Dementia
317735
0
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Multiple sclerosis
317736
0
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Insomnia
317737
0
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Inflammatory bowel disease/Irritable bowel syndrome
317738
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Condition category
Condition code
Anaesthesiology
315799
315799
0
0
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Pain management
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Neurological
315800
315800
0
0
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Epilepsy
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Mental Health
315801
315801
0
0
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Other mental health disorders
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Neurological
315802
315802
0
0
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Other neurological disorders
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Neurological
315804
315804
0
0
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Parkinson's disease
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Neurological
315805
315805
0
0
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Dementias
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Neurological
315806
315806
0
0
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Multiple sclerosis
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Oral and Gastrointestinal
315808
315808
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Assess safety, tolerability and efficacy of medicinal cannabis (MediCabilis) being prescribed for any indication.
This is a multi-site, observational cohort study, examining the effect of oral cannabidiol in participants receiving MediCabilis for their conditions. Most of the Cannabis Clinics, monitor a range of patient reported outcome and experience measures at defined intervals over the treatment period as part of routine care.
This study is designed to collect patient data (demographic, medical history, diagnosis) and also a range of validated patient-reported outcome and experience measures for patients who have received MediCabilis.
Patients will be observed for up to 12 months.
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Intervention code [1]
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Not applicable
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Comparator / control treatment
Observational study, No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Adverse events (AEs) associated with medicinal cannabis treatment (as reported by participants or recorded by the health care team).
The most commonly experienced adverse effects are:
- drowsiness
- nausea
- sedation
- altered sensory perception
Unlikely but potential psychiatric adverse events include:
- depression
- disorientation
- feeling over-excited or losing touch with reality
- have difficulty speaking
- eating (more or less than usual)
- hallucinations
Adverse events will be evaluated through patient (or carer's) self-reporting using an Electronic Patient Reporting (ePRO) system or from observations made by health-care practitioners during standard care.
Participants or their carers will be able to report patient outcomes using the IBM clinical development platform that can be accessed on mobile apps or through a website link.
Healthcare practitioners will collect data using study-specific questioners, and health records that are obtained during standard care using standard procedures. These will also be entered into the IBM clinical development platform.
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Assessment method [1]
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Timepoint [1]
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baseline, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
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Secondary outcome [1]
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Patient reported outcomes using questionnaires(Treatment Satisfaction Questionnaire for Medication (TSQM)
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Assessment method [1]
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Timepoint [1]
383547
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baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
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Secondary outcome [2]
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Patient reported outcomes for patients with post-traumatic stress disorder using the questionnaire, The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
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Assessment method [2]
383548
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Timepoint [2]
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baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
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Secondary outcome [3]
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Patient-Reported Outcomes Measurement Information System
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Assessment method [3]
384073
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Timepoint [3]
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baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
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Secondary outcome [4]
384659
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Brief Pain Inventory
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Assessment method [4]
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Timepoint [4]
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baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
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Eligibility
Key inclusion criteria
Participants will be any patient who has been prescribed MediCabilis through the Special Access Scheme B or by an authorised prescriber.
Participants may be taking MediCabilis in any dose, form, duration and free
quency, and for any condition.
Patients of any gender who is equal or greater than 18 years may participate.
Prospective patients that understand the informed consent process and to give informed consent to participate in the study.
Diagnosis of their condition/disease confirmed by patient’s GP or specialist.
Prospective participants agree to abstain from using illicit cannabis products for the duration of their participation in the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Any severe cognitive, intellectual disability, medical or psychiatric condition that impairs the participant’s ability to provide informed consent.
Patients who are using illicit forms of cannabis.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Data will be analysed using SPSS (v25.0, IBM Analytics). Descriptive statistics will be produced, with summary data regarding participant demographics, treatment and patient-reported assessments. Continuous variables with normal distribution will be presented as means with standard deviation; non-normal distribution will be presented as medians with an interquartile range (IQR). Categorical variables will be presented as counts and percent of the total.
The study will use t-test for the analysis of the continuous variables with normal distribution, and non-parametric Wilcoxon test used whenever parametric assumptions are not satisfied. Longitudinal outcome data overtime (i.e. changes from baseline) will be analysed using repeated measures analysis (e.g. ANOVAs or ANCOVAs to correct for any confounding variables).
Multivariate Logistic regression will be used to analyse factors associated with treatment outcomes and Bonferroni-corrected to adjust for multiple testing.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
20/07/2020
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Actual
29/07/2020
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Date of last participant enrolment
Anticipated
30/06/2021
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Actual
30/09/2021
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Date of last data collection
Anticipated
30/06/2022
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Actual
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Sample size
Target
500
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Accrual to date
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Final
479
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Bod Australia
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Address [1]
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Level 1, 377 New South Head Road
DOUBLE BAY NSW 2028
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Bod Australia
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Address
Level 1, 377 New South Head Road
DOUBLE BAY NSW 2028
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
306324
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306134
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Bellberry Ethics Committee
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Ethics committee address [1]
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129 Glen Osmond Rd Eastwood SA 5063
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/02/2020
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Approval date [1]
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13/05/2020
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Ethics approval number [1]
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2020-02-174
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Summary
Brief summary
This study is a multicenter, open label, longitudinal observational study aiming to assess the safety, tolerability and efficacy of MediCabilis™ when used at the prescribed dose by physicians for different indications using data reported by patients during treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Ben Jansen
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Address
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Medical On Miami
2125 Gold Coast Highway, Miami QLD 4220
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Country
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Australia
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Phone
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+61 07 5689 3740
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Adele Hosseini
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Address
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Bod Australia
Level 1, 377 New South Head Road
Double Bay NSW 2038 NSW
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Country
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Australia
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Phone
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+61 2 9199 5080
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Adele Hosseini
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Address
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Bod Australia
Level 1, 377 New South Head Road
Double Bay NSW 2038 NSW
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Country
102828
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Australia
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Phone
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+61 2 9199 5080
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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