ANZCTR - Registration

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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]

RC56221

Universal Trial Number (UTN)

U1111-1197-0970

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

osteoarthritis

Condition category

Condition code

Musculoskeletal

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]

Treatment: Drugs

Intervention code [2]

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]

VAS rating of pain on movement

Timepoint [1]

48 hours

Primary outcome [2]

WOMAC pain score

Timepoint [2]

48 hours

Primary outcome [3]

WOMAC function score

Timepoint [3]

48 hours

Secondary outcome [1]

VAS resting pain rating

Timepoint [1]

48 hours

Secondary outcome [2]

Aggregated locomotor function (ALF) test completion time

Timepoint [2]

48 hours

Secondary outcome [3]

Pressure Pain Threshold asessed using a digital algometer

Timepoint [3]

48 hours

Secondary outcome [4]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6845 - Perth

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Industry, Innovation and Science

Address [1]

Department of Industry, Innovation and Science
GPO Box 2013
Canberra, ACT, 2601

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

OBJ Ltd

Address [2]

284 Oxford St
Leederville
Western Australia 6007

Country [2]

Australia

Primary sponsor type

University

Name

Curtin University

Address

GPO Box U1987
Perth, WA 6845

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Prof Tony Wright

Address [1]

School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

Curtin University
GPO Box U1987
Perth, WA 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/06/2017

Approval date [1]

14/08/2017

Ethics approval number [1]

HRE2017-0528

Summary

Brief summary

Osteoarthritis is a long term degenerative disease process that affects the major joints. Osteoarthritis pain and inflammation is often treated using non-steroidal anti-inflammatory drugs (NSAIDs). In some cases these drugs can be applied through the skin to treat the affected joint below. The skin however provides a significant barrier to drug penetration. Various methods can be used to enhance drug penetration through the skin. In this case the method of enhancement will be by using a low level magnetic field (similar to a fridge magnet). The aim of this study is to evaluate changes in pain and function following short term (48 hours) use of ibuprofen (5%), a topical NSAID, administered in a patch with a magnetic backing strip. The magnetic backing is designed to enhance the absorption of ibuprofen. The ibuprofen patch will be compared to a placebo patch containing no drug and no magnetic backing.
The main objective is to determine if the magnetically enhanced ibuprofen patch achieves superior outcomes to placebo in reducing pain and improving function over 48 hours.
The primary hypothesis is that the transdermal ibuprofen magnetic patch will result in significantly lower ratings of pain on movement compared to placebo.
The pilot study will recruit a group of 24 participants with knee osteoarthritis. Each participant will complete 2, 48 hour study periods. At the start of each study period they will have their current pain and function assessed in a University laboratory. Participants will then have a patch containing either ibuprofen or placebo applied to their knee(s). When this testing has been completed they will be given an iPad which they will use to complete further testing over a 48 hour period as they go about their normal activities while wearing the knee patch. The iPad will prompt them to complete a rating of their pain at rest and pain on movement approximately every 2.5 hours and it will remind them to change the patch approximately every five hours. After 48 hours they will return to the research laboratory and complete the other pain and function tests. After an interval of 1 week all participants will return to the laboratory and complete the full 48 hour testing process while wearing the alternative patch (placebo or ibuprofen). Neither the participants nor the researchers will know on which occasion they received the ibuprofen treatment.
It is envisaged that the participants pain levels will be less and their function will be better during the period in which they are wearing the ibuprofen patch. This is a pilot study gathering preliminary data from a relatively small number of participants. The data from the study will be used by the company that has commissioned the research to inform a future large randomised, controlled clinical trial.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Tony Wright

Address

School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845

Country

Australia

Phone

+61 8 9266 3675

Fax

T.Wright@curtin.edu.au

Contact person for public queries

Name

Tony Wright

Address

School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845

Country

Australia

Phone

+61 8 9266 3675

Fax

T.Wright@curtin.edu.au

Contact person for scientific queries

Name

Tony Wright

Address

School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845

Country

Australia

Phone

+61 8 9266 3675

Fax

T.Wright@curtin.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Monitoring the clinical response to an innovative transdermal delivery system for ibuprofen.	2019	https://dx.doi.org/10.3390/pharmaceutics11120664

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically