Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000412033
Ethics application status
Approved
Date submitted
12/05/2010
Date registered
21/05/2010
Date last updated
21/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of the irritation and sensitization of an opioid analgesic gel applied to the skin in healthy volunteers.
Scientific title
A repeat insult patch test (RIPT) to evaluate the irritation and sensitization of transdermally delivered oxycodone in combination with the novel penetration enhancer, tocopheryl phosphate mix (TPM) in healthy volunteers.
Secondary ID [1] 251739 0
POH019-09 (Phosphagenics clinical trial identifier)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritation 257347 0
Sensitization 257357 0
Condition category
Condition code
Skin 257492 257492 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consists of 1 test group.
A gel containing Tocopheryl phosphate mix in combination with approximately 9 mg of oxycodone (TPM/O).
TPM/O will be applied and covered using an occlusive patch to 50 healthy volunteers for a series of nine consecutive 24 hour exposures, every day.
Intervention code [1] 256459 0
Treatment: Drugs
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258410 0
To determine the irritation and sensitization of tocopheryl phosphate mix combined with oxycodone (TPM/O) after transdermal applications.
Visual evaluations of skin reactions will be scored according to a "skin response table".
Timepoint [1] 258410 0
After removal of patches and immediately prior to each subsequent dose on days 1, 3, 5, 7, 9, 11, 13, 15, 17 and 28.
Secondary outcome [1] 264164 0
n/a
Timepoint [1] 264164 0
n/a

Eligibility
Key inclusion criteria
1. Male and female participants aged 18 to 49 years inclusive.
2. Participants who are not presently and have not for a period of 30 days prior to screening, been under the influence of prescription medication.
3. Able to read, understand and adhere to the study visits and procedures.
4. Participants who provide written informed consent for participation in this study.
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participants who, in the opinion of the investigator, may express a negative reaction to a test sample based upon medical history or other pre-test conditions.
2. Pregnant or lactating females. Females of child bearing potential who do not agree to use highly effective methods of birth control.
3. Participants currently under a doctor's care.
4. Participant who intend to become pregnant within the next 60 days.
5. Participants who have taken any anti-inflammatories, anti-histamines, steroids (topical or oral) or prescription medication within 30 days prior to screening (not including sunscreen), with the exception of contraception for females; or any over the counter medications within 48 hours prior to screening;
6. Participants who exhibit physical or dermatological conditions, which would preclude application of the test material.
7. Known allergy or hypersensitivity reactions to oxycodone or other opioid analgesics or allergy to any contents of the gel.
8. Known allergy or hypersensitivity to tapes, patches, adhesives or to topical preparations, such as sunscreens.
9. Participants who have participated in a clinical trial or received an experimental therapy within 30 days prior to dosing.

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256958 0
Commercial sector/Industry
Name [1] 256958 0
Phosphagenics Limited
Country [1] 256958 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street
Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 256222 0
None
Name [1] 256222 0
Address [1] 256222 0
Country [1] 256222 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258956 0
Bellberry Limited
Ethics committee address [1] 258956 0
Ethics committee country [1] 258956 0
Date submitted for ethics approval [1] 258956 0
Approval date [1] 258956 0
Ethics approval number [1] 258956 0

Summary
Brief summary
The purpose of this study is to determine if tocopheryl phosphate mix, in combination with oxycodone (TPM/O) in the form of a patch, will cause irritation when applied daily for a long period of time (9 consecutive days).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31151 0
Address 31151 0
Country 31151 0
Phone 31151 0
Fax 31151 0
Email 31151 0
Contact person for public queries
Name 14398 0
Yelda Ogru
Address 14398 0
Phosphagenics Limited
11 Duerdin Street
Clayton, VIC 3168
Country 14398 0
Australia
Phone 14398 0
61395651156
Fax 14398 0
Email 14398 0
[email protected]
Contact person for scientific queries
Name 5326 0
Yelda Ogru
Address 5326 0
Phosphagenics Limited
11 Duerdin Street
Clayton, VIC 3168
Country 5326 0
Australia
Phone 5326 0
61395651156
Fax 5326 0
Email 5326 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
No additional documents have been identified.