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Trial registered on ANZCTR


Registration number
ACTRN12619000513112
Ethics application status
Approved
Date submitted
6/02/2019
Date registered
1/04/2019
Date last updated
12/02/2020
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational study investigating and auditing the safety, tolerability and further efficacy characteristics of a pharmaceutical grade cannabis medicine (NanaBis™) prescribed to eligible patients for the management of cancer related or non-cancer related pain in general and specialty medical practices.
Scientific title
An observational study investigating and auditing the safety, tolerability and further efficacy characteristics of a pharmaceutical grade cannabis medicine (NanaBis™) prescribed to eligible patients for the management of cancer related or non-cancer related pain in general and specialty medical practices.
Secondary ID [1] 297322 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer related pain 311433 0
non-cancer related pain 311540 0
Condition category
Condition code
Cancer 310072 310072 0 0
Any cancer
Anaesthesiology 310178 310178 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational, multicentre study conducted in Australia with patients who are about to start a therapy with NanaBis™ for the management of cancer related or non-cancer related pain. Patients are to be enrolled into the study no earlier than the Consenting Doctor’s decision to initiate treatment with NanaBis™. It is mandatory that the prescriber’s decision to start treatment with NanaBis™ was taken independently and before the decision to give the patient the option to participate in the study. Consenting Doctors' clinics will be asked to progressively enrol eligible patients until the maximum inclusion threshold is reached. Participants will be followed monthly for a maximum of 12 months from the signing of the informed consent or until death, withdrawal of consent, loss of follow-up/record, whichever comes first. During the follow-up visits (which will take approximately 15-20 minutes) assessments will be performed according to routine local clinical practice. De-identified data collected at each visit and reported to the Sponsor must include the information listed under ‘Study Procedures’. Follow-up de-identified patient reports detailing the required information will be sent to the Sponsor for a maximum of 12 months (Reports to coincide with patient visit for follow-up consultation and/or new NanaBis™ prescription).
Intervention code [1] 313576 0
Not applicable
Comparator / control treatment
No control group nor comparison between cancer and non cancer pain.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318967 0
Adverse Events/Serious Adverse Events that may have occurred (as reported by participants or recorded by Consenting Doctor and/or measured by blood test results such as FBC, LFT and GFR – if available and performed as part of routine patient monitoring) and resolution thereof (safety);
Possible side effects: As THC in NanaBis™ is a psychoactive compound, high doses of NanaBis™ may increase the risk of serious psychiatric adverse events including psychosis, hallucinations, delusions, depression, paranoia and homicidal and suicidal ideation.
Other side effects:
Very common (affecting more than 1 in 10 people)
• feeling dizzy or tired
• feeling hungry
• problems with their memory or having trouble concentrating
• changed sense of taste or a dry mouth
Common (affecting less than 1 in 10 people)
• lack of energy or feeling weak or generally unwell
• problems with their memory or having trouble concentrating
• feeling abnormal or drunk
• feeling sleepy or drowsy
• blurred vision
• constipation or diarrhoea
• feeling nauseous or vomiting
• loss of balance or falling over
• mouth problems, including burning, pain or mouth ulcers
• feeling depressed or disorientated
• feeling over-excited or losing touch with reality
• difficulty speaking
• seeing or hearing things that are not there (hallucinations)
Uncommon (affecting less than 1 in 100 people)
• stomach pain
• sore throat or throat irritation
• mouth or teeth changing colour
• irritation where NanaBis™ is sprayed
• red and swollen mouth or peeling inside the mouth
• delusional thoughts
• paranoid thoughts / feeling that other people are against them
• fast or irregular heartbeats, also called palpitations
• fainting



Timepoint [1] 318967 0
Once a month for twelve months.
Primary outcome [2] 319590 0
Participant withdrawal from the study and/or reason for discontinuation for NanaBis™
Timepoint [2] 319590 0
Once a month for twelve months.
Primary outcome [3] 319591 0
NanaBis™ indication/dosage for prescribing, reported by the prescriber via monthly report.
Timepoint [3] 319591 0
Once a month for twelve months.
Secondary outcome [1] 366555 0
Efficacy of drug in treating pain, assessed with pain and quality of life questionnaires BPI-SF and SF-12.

Timepoint [1] 366555 0
Once a month for twelve months.
Secondary outcome [2] 368806 0
Concomitant Medications and changes thereof, reported by the prescriber via monthly report.
Timepoint [2] 368806 0
Once a month for twelve months.
Secondary outcome [3] 368807 0
Current medical diagnosis as reported by the prescribing doctor and participant medical records.
Timepoint [3] 368807 0
Once a month for twelve months.
Secondary outcome [4] 368809 0
Number of vials prescribed with each prescription written during the study, reported by the prescriber via monthly report.
Timepoint [4] 368809 0
Once a month for twelve months.
Secondary outcome [5] 369258 0
Rationale for NanaBis™ prescription/administration (describe type of pain)
Timepoint [5] 369258 0
Once a month for twelve months
Secondary outcome [6] 369259 0
Starting dose for NanaBis™
Timepoint [6] 369259 0
Once a month for twelve months
Secondary outcome [7] 369260 0
Number of vials consumed since previous visit as reported by the participant.
Timepoint [7] 369260 0
Once a month for twelve months
Secondary outcome [8] 369261 0
Rationale for changes in NanaBis™ prescribed dosage as reported by the prescribing doctor
Timepoint [8] 369261 0
Once month for twelve months.

Eligibility
Key inclusion criteria
1. Prospective participants greater than or equal to 18 years of age at time of entry on study;
2. Prospective participants have the cognitive ability to understand the informed consent process and to give informed consent to participate in the observational study;
3. Prospective participants have been lawfully prescribed NanaBis™ by their Consenting Doctor;
4. Prospective participants are prescribed NanaBis™ for the management of cancer related or non-cancer related pain;
5. Prospective participants are able to visit the Consenting Doctor as required while administering NanaBis™ and are able to provide information as required to the Consenting Doctor for the duration of the study;
6. Prospective participants agree to abstain from using cannabis products other than NanaBis™ for the duration of their participation in the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Prospective participants will be ineligible if they are under the age of 18 years;
2. Prospective participants will be ineligible if they are unwilling or unable to sign the Informed Consent Form or cannot understand the Participant Information Sheet provided;
3. Prospective participants will be ineligible if the Consenting Doctor determines that the prospective participant is unable to fulfill any of the requirements of the study;
4. Prospective participants will be ineligible if they are unwilling or unable to perform study procedures as described in the study protocol.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study is descriptive in nature and no formal hypotheses will be tested. As this is not a study with pre-specified hypotheses, no comparative analyses assessing the effectiveness of other treatments will be undertaken.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301890 0
Commercial sector/Industry
Name [1] 301890 0
Medlab Clinical
Address [1] 301890 0
66 McCauley Street, Alexandria NSW 2015
Country [1] 301890 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
66 McCauley Street, Alexandria NSW 2015
Country
Australia
Secondary sponsor category [1] 301642 0
None
Name [1] 301642 0
Address [1] 301642 0
Country [1] 301642 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302579 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 302579 0
21 (11-23) Burwood Road, Hawthorn, Melbourne, Victoria 3122
Ethics committee country [1] 302579 0
Australia
Date submitted for ethics approval [1] 302579 0
29/01/2019
Approval date [1] 302579 0
17/06/2019
Ethics approval number [1] 302579 0
0052E_2019

Summary
Brief summary
The purpose of this study is to investigate the safety, tolerability and effectiveness of pharmaceutical grade cannabis for the management of pain.

Who is it for?

You may be eligible for this study if you are an adult who has been prescribed NanaBis™ for either cancer-related or non-cancer related pain.

Study details

All participants will be followed up by their doctors on a monthly basis for 12 months. These follow ups will involve completion of surveys and provision of information regarding the administration of NanaBis™. Participants will not be asked to undergo any procedures or tests as part of this study.

It is hoped that this study will help determine whether pharmaceutical grade cannabis is an options for pain management.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90710 0
Prof Luis Vitetta
Address 90710 0
Medlab Clinical Ltd
66 McCauley Street, Alexandria NSW 2015
Country 90710 0
Australia
Phone 90710 0
+61 2 8188 0311
Fax 90710 0
Email 90710 0
luis_vitetta@medlab.co
Contact person for public queries
Name 90711 0
Ms Kavya Potlapelly
Address 90711 0
Medlab Clinical Ltd
66 McCauley Street, Alexandria NSW 2015
Country 90711 0
Australia
Phone 90711 0
+61 2 8188 0311
Fax 90711 0
Email 90711 0
kavya_potlapelly@medlab.co
Contact person for scientific queries
Name 90712 0
Prof Luis Vitetta
Address 90712 0
Medlab Clinical Ltd
66 McCauley Street, Alexandria NSW 2015
Country 90712 0
Australia
Phone 90712 0
+61 2 8188 0311
Fax 90712 0
Email 90712 0
luis_vitetta@medlab.co

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results