Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000505202
Ethics application status
Approved
Date submitted
10/06/2009
Date registered
24/06/2009
Date last updated
10/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase 1 study in healthy volunteers to determine the dermatopharmacokinetics of topically applied diclofenac in combination with the novel penetration enhancer Tocopheryl Phosphate Mixture (TPM), compared with Votaren(registered trademark) gel
Scientific title
A phase 1 study in healthy volunteers to determine the dermatopharmacokinetics of topically applied diclofenac in combination with the novel penetration enhancer Tocopheryl Phosphate Mixture (TPM), compared with Votaren (registered trademark) gel
Secondary ID [1] 284066 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscular or joint pain relief in healthy volunteers currently experiencing no pain 237073 0
Condition category
Condition code
Other 237310 237310 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A gel mixture of Tocopheryl Phosphate Mixture (TPM) and Diclofenac 1% and 2% applied topically to the volar forearms once for a 6 hour period.
Each subject will receive 4 applications of 62.5mg each of each concentration
Intervention code [1] 236737 0
Treatment: Drugs
Comparator / control treatment
Voltaren Emulgel 1% applied topically to the volar forearms once for a 6 hour period.
Each subject will receive 4 applications of 62.5mg each of Voltaren
Control group
Active

Outcomes
Primary outcome [1] 238127 0
Safety and tolerabilty of TPM/diclofenac assessed via adverse event monitoring and reporting.
Timepoint [1] 238127 0
Day 1 (dosing day) and Day 7 (follow up post dose)
Secondary outcome [1] 242334 0
Dermatopharmacokinetics of TPM/diclofenac assessed by analysis of skin samples obtained by tape stripping
Timepoint [1] 242334 0
Day 1 pre dose and 1, 2, 4 and 6 hours post dose

Eligibility
Key inclusion criteria
Healthy males and females aged 18 to 55 years inclusive.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant or breast-feeding, skin conditions preventing gel application, current clinically significant medical conditions, on chronic medications, on medications which may interact with non-steroidal anti-inflamatory drugs

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
17/10/2008
Date of last participant enrolment
Anticipated
Actual
18/12/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237135 0
Commercial sector/Industry
Name [1] 237135 0
Phosphagenics Limited
Country [1] 237135 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin St
Clayton Victoria 3168
Country
Australia
Secondary sponsor category [1] 4625 0
None
Name [1] 4625 0
Address [1] 4625 0
Country [1] 4625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239228 0
Ethics committee address [1] 239228 0
Ethics committee country [1] 239228 0
Date submitted for ethics approval [1] 239228 0
30/06/2008
Approval date [1] 239228 0
09/10/2008
Ethics approval number [1] 239228 0

Summary
Brief summary
This study is being conducted to see if a TPM/Diclofenac gel mix will penetrate into the skin more, and more quickly, than Voltaren. It will also assess how safe the gel mix is.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29724 0
Dr Alex Veldman
Address 29724 0
Phosphagenics Limited 11 Duerdin St Clayton Victoria 3168
Country 29724 0
Australia
Phone 29724 0
+61 3 9565 1119
Fax 29724 0
Email 29724 0
pgavin@phosphagenics.com
Contact person for public queries
Name 12971 0
Dr Paul Gavin
Address 12971 0
Phosphagenics Limited
11 Duerdin St
Clayton Victoria 3168
Country 12971 0
Australia
Phone 12971 0
+61 3 9565 1119
Fax 12971 0
Email 12971 0
pgavin@phosphagenics.com
Contact person for scientific queries
Name 3899 0
Dr Paul Gavin
Address 3899 0
Phosphagenics Limited
11 Duerdin St
Clayton Victroria 3168
Country 3899 0
Australia
Phone 3899 0
+61 3 9565 1119
Fax 3899 0
Email 3899 0
pgavin@phosphagenics.com

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
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