Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000841370
Ethics application status
Approved
Date submitted
1/06/2017
Date registered
7/06/2017
Date last updated
11/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial to evaluate magnetically enhanced ibuprofen delivery in people with knee osteoarthitis
Scientific title
Double-blind, randomized pilot study to evaluate the effect of diamagnetically enhanced transdermal ibuprofen in comparison to placebo on pain and function in individuals with knee osteoarthritis
Secondary ID [1] 292085 0
RC56221
Universal Trial Number (UTN)
U1111-1197-0970
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 303526 0
Condition category
Condition code
Musculoskeletal 302938 302938 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The kneeguard patch is a transdermal patch containing ibuprofen 5% (125 mg) in a silicon gel. The patch has a magnetic backing layer made from strontium ferrite crystals encapsulated in a PVC matrix. The patch will be applied 3 times per day for a period of 6 hours. The duration of the trial will be 48 hours. The patch will be applied by the study participant. They will receive reminders from an iPad application when the patch is due to be changed and they will need to indicate in that app when the have re-applied the patch (as a means to monitor adherence).
There will be a minimum washout period of 5 days between test sessions.
Intervention code [1] 298252 0
Treatment: Drugs
Intervention code [2] 298253 0
Treatment: Devices
Comparator / control treatment
The comparator will be a placebo patch containing no ibuprofen and with a non-magnetised backing but otherwise similar in appearance.
Control group
Placebo

Outcomes
Primary outcome [1] 302335 0
VAS rating of pain on movement
Timepoint [1] 302335 0
48 hours
Primary outcome [2] 302336 0
WOMAC pain score
Timepoint [2] 302336 0
48 hours
Primary outcome [3] 302337 0
WOMAC function score
Timepoint [3] 302337 0
48 hours
Secondary outcome [1] 335555 0
VAS resting pain rating
Timepoint [1] 335555 0
48 hours
Secondary outcome [2] 335556 0
Aggregated locomotor function (ALF) test completion time
Timepoint [2] 335556 0
48 hours
Secondary outcome [3] 335557 0
Pressure Pain Threshold asessed using a digital algometer
Timepoint [3] 335557 0
48 hours
Secondary outcome [4] 335605 0
Skin irritation ratings categorized on a 4 point scale according to severity, with 3 indicating skin breakdown (e.g., blistering, raw, breakdown of the skin etc.), 2 indicating minor changes in the skin condition (e.g., dry, flaky, red or rash), 1 indicating symptoms of altered sensation (e.g., itchy, heat, tingling) and 0 indicating no reaction at all.
Timepoint [4] 335605 0
Assessed at 24 hours (by telephone) and 48 hours

Eligibility
Key inclusion criteria
Medically diagnosed painful knee osteoarthritis (Pain rating greater than or equal to 4 of 10) based on ACR guidelines
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of neurological disorders affecting sensory, motor or cognitive function; recent lower limb injury or surgery; history of other chronic pain disorders; history of Gastric ulcers or renal disease; known or suspected allergy/sensitivity to ibuprofen; known or suspected allergy/sensitivity to adhesive or tape; history of any serious adverse events related to previous NSAID use.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed. Allocation determined by central holder of randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis of variance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/07/2017
Actual
30/08/2017
Date of last participant enrolment
Anticipated
5/03/2018
Actual
19/02/2018
Date of last data collection
Anticipated
7/03/2018
Actual
28/02/2018
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 16297 0
6845 - Perth

Funding & Sponsors
Funding source category [1] 296616 0
Government body
Name [1] 296616 0
Department of Industry, Innovation and Science
Country [1] 296616 0
Australia
Funding source category [2] 296644 0
Commercial sector/Industry
Name [2] 296644 0
OBJ Ltd
Country [2] 296644 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 295601 0
Individual
Name [1] 295601 0
Prof Tony Wright
Address [1] 295601 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country [1] 295601 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297848 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 297848 0
Ethics committee country [1] 297848 0
Australia
Date submitted for ethics approval [1] 297848 0
09/06/2017
Approval date [1] 297848 0
14/08/2017
Ethics approval number [1] 297848 0
HRE2017-0528

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75254 0
Prof Tony Wright
Address 75254 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 75254 0
Australia
Phone 75254 0
+61 8 9266 3675
Fax 75254 0
Email 75254 0
[email protected]
Contact person for public queries
Name 75255 0
Tony Wright
Address 75255 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 75255 0
Australia
Phone 75255 0
+61 8 9266 3675
Fax 75255 0
Email 75255 0
[email protected]
Contact person for scientific queries
Name 75256 0
Tony Wright
Address 75256 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 75256 0
Australia
Phone 75256 0
+61 8 9266 3675
Fax 75256 0
Email 75256 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseMonitoring the clinical response to an innovative transdermal delivery system for ibuprofen.2019https://dx.doi.org/10.3390/pharmaceutics11120664
N.B. These documents automatically identified may not have been verified by the study sponsor.