Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001512819
Ethics application status
Approved
Date submitted
9/09/2021
Date registered
5/11/2021
Date last updated
13/05/2022
Date data sharing statement initially provided
5/11/2021
Date results information initially provided
13/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single Centre Observational Study to Assess whether a Topically Applied Cannabidiol Gel can Reduce Symptoms of Painful Osteoarthritis of the Hand
Scientific title
A Single Centre Observational Study to Assess whether a Topically Applied Cannabidiol Gel can Reduce Pain, Increase Grip Strength, or Improve Joint Functionality for Sufferers of Painful Osteoarthritis of the Hand
Secondary ID [1] 305271 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the hand 323569 0
Condition category
Condition code
Musculoskeletal 321118 321118 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment product is a topical 4% w/w Cannabidiol gel that is applied 3 times per day over a four week period to joints of the hand suffering painful arthritis. The product is supplied in a metered pump that administers 0.25 ml. Subjects will be instructed to apply a single 0.25 ml pump to the affected hand at each application. The gel will then be massaged into the joints of the hand affected by arthritis.

Subjects will complete a questionnaire each night via their smart-phone, that will ask them to confirm that they have adhered to the application instructions that day as described by the protocol.
Intervention code [1] 321674 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328892 0
Changes in hand pain as assessed by the Numeric Pain Rating Scale (NPRS)
Timepoint [1] 328892 0
Pain scores will be recorded on a daily basis during week 1 to calculate baseline pain scores. Pain scores will be recorded on a daily basis from weeks 2-5 to accompany the 4 week dosing period. The primary outcome will compare pain scores 4 weeks post commencement with those obtained at baseline to determine whether the treatment has had any effect..
Secondary outcome [1] 400812 0
Changes in grip strength as assessed by a squeeze ball dynamometer connected via Bluetooth to a recording app
Timepoint [1] 400812 0
Grip strength will be recorded on a daily basis during week 1 to calculate baseline scores. Grip strength will be recorded on a daily basis from weeks 2-5 to accompany the 4 week dosing period. The secondary outcome will compare grip strength scores 4 weeks post commencement with those obtained at baseline to determine whether the treatment has had any effect..
Secondary outcome [2] 401565 0
Changes in hand functionality as measured by the Functional Index for Hand OsteoArthritis (FIHOA) score.
Timepoint [2] 401565 0
FIHOA scores will be recorded on a weekly basis. FIHOA scores at 4 weeks will be compared with those recorded at Baseline..

Eligibility
Key inclusion criteria
- Males and females with symptomatic hand OA affecting the fingers and thumb.
- At least 3 joints affected by distal interphalangeal (DIP) nodal hand OA, defined by Heberden's Nodes on physical exam.
- At least one DIP nodal hand OA with:
-Sufficiently severe frequent pain, as categorized by a minimum NPRS pain severity of 3 on a 0 - 10 scale.
-Frequent pain: pain on most days of the month for at least one month in the last year.
- Access to the internet and a smart phone, and the ability to use an app.
- Able to understand and sign the Informed Consent Form.
- Willing to follow the protocol requirements and comply with protocol restrictions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History or current inflammatory arthritis (examples: gout, psoriatic arthritis, and rheumatoid arthritis).
- Medications and/or medical conditions that are likely to change over the 6-week trial period.
- Prior surgery on the DIP joints.
- Pregnancy or lactation.
- Dermatology conditions of the hand.
- Regular self-reported use of cannabis, or cannabis-based products during the past three months.
- Known allergies or hypersensitivity to cannabis-based products or any of the excipients in the study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2022
Actual
5/02/2022
Date of last participant enrolment
Anticipated
Actual
5/02/2022
Date of last data collection
Anticipated
Actual
19/03/2022
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309640 0
Charities/Societies/Foundations
Name [1] 309640 0
Lambert Initiative for Cannabinoid Therapeutics
Country [1] 309640 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Avecho Biotechnology
Address
Unit A8,
2A Westall Road
Clayton, 3168
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 310659 0
None
Name [1] 310659 0
Address [1] 310659 0
Country [1] 310659 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309413 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 309413 0
123 Glen Osmond Road, Eastwood, South Australia, 5063
Ethics committee country [1] 309413 0
Australia
Date submitted for ethics approval [1] 309413 0
28/07/2021
Approval date [1] 309413 0
20/10/2021
Ethics approval number [1] 309413 0

Summary
Brief summary
This study will assess whether topical application of a CBD gel can provide analgesia for patients suffering from osteoarthritis of the hand.

A growing body of evidence suggests that inflamed tissue caused by osteoarthritis may be susceptible to treatment using CBD. Despite oral ingestion of cannabinoid products being the preferred route of administration, its poor aqueous solubility and extensive first-pass metabolism lead to poor bioavailability, which limits see its potential efficacy. The ability to deliver CBD directly to local, inflamed tissue using topical application may provide superior analgesia than oral dosage forms, whilst minimising any concerns related to systemic exposure.

This study will assess whether topical application of a CBD gel can provide analgesia for patients suffering from osteoarthritis of the hand. In addition to analgesia, the study will investigate whether topical CBD can provide benefits for other symptoms of osteoarthritis of the hand; poor grip strength and hand functionality. Results from this study will support further clinical development of the CBD gel, as well as future prescribing to patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114070 0
Dr Daniel Lewis
Address 114070 0
The Lewis Institute for Health and Wellbeing
73 Chapel St
St Kilda VIC 3182 AUSTRALIA
Country 114070 0
Australia
Phone 114070 0
+613 95349495
Fax 114070 0
Email 114070 0
daniel.lewis@daniellewis.com.au
Contact person for public queries
Name 114071 0
Dr Daniel Lewis
Address 114071 0
The Lewis Institute for Health and Wellbeing
73 Chapel St
St Kilda VIC 3182 AUSTRALIA
Country 114071 0
Australia
Phone 114071 0
+613 95349495
Fax 114071 0
Email 114071 0
daniel.lewis@daniellewis.com.au
Contact person for scientific queries
Name 114072 0
Dr Daniel Lewis
Address 114072 0
The Lewis Institute for Health and Wellbeing
73 Chapel St
St Kilda VIC 3182 AUSTRALIA
Country 114072 0
Australia
Phone 114072 0
+613 95349495
Fax 114072 0
Email 114072 0
daniel.lewis@daniellewis.com.au

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 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.