Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000847213
Ethics application status
Approved
Date submitted
30/09/2009
Date registered
30/09/2009
Date last updated
21/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A repeat patch application study to determine what the body does to oxycodone in combination with tocopheryl phosphate mix, when delivered through the skin.
Scientific title
A phase I randomised, repeat patch application study in healthy male volunteers, to determine the pharmacokinetic profile of transdermally delivered oxycodone in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM).
Secondary ID [1] 251729 0
POH023-09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To promote pain relief in healthy volunteers. 251942 0
Condition category
Condition code
Anaesthesiology 252127 252127 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consists of two test groups.
1. A reservoir patch system containing 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone and;
2. A matrix patch system containing 40mg Tocopheryl Phosphate Mix (TPM) and 200mg Oxycodone.
Subjects will be randomly assigned to receive only one of the above treatments.
Both groups will receive the study drug in their allocated patch form containing 200mg Oxycodone. The 200mg will be divided into two 100mg patches applied to each upper outer thigh region. The patch will remain in place for 23 hours and 30 minutes from the time of application and a new patch applied 30 minutes later. This will occur daily, for 10 days, for all volunteers.
The matrix patch is made of a solid film polymer whereas the reservoir patch is made of TPM gel enclosed in a semi-permeable membrane.
Intervention code [1] 241361 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253006 0
To compare the relative bioavailability of a reservoir and matrix patch system containing TPM after repeated application.
Timepoint [1] 253006 0
Blood samples will be collected within 15 minutes prior to dosing (0hr) and 6 hourly from 0 to 240 hrs and then 8 hourly from 240 to 408 hours post-dose.
Secondary outcome [1] 257779 0
To evaluate the tolerability and safety of oxycodone in novel formulations containing TPM after repeated application.
Timepoint [1] 257779 0
- Vital signs will be checked at screening and at Day -2, Check-in, Day -1, prior to receiving treatment on Day 1, 12 hourly throughout the in-house stay and Day 25 (exit visit).
- An Electrocardiograph (ECG) will be taken at screening and the exit visit.
- Clinical Laboratory measurements will be performed at screening, Day -1, Day 5, Day 10, Day 18 and Day 25 (exit visit).

Eligibility
Key inclusion criteria
- Male and aged 18-49 years (inclusive)
- Healthy subjects (healthy defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, 12-lead ECG and clinical laboratory determinations.
- Body mass index (BMI) equal or greater than 19 and equal or less than 30kg/m2
- Weight is greater than 50 kg
- Adequate venous access in the left or right arm to allow collection of a number of blood samples
- Fluent in the English language
- Able to provide written informed consent to participate in the study and be willing to comply with the study procedures
Minimum age
18 Years
Maximum age
49 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History or evidence of drug or alcohol abuse and/or positive repeat urine/breath results prior to start of the study
- Individuals who smoked an average of one or more cigarette or tobacco form (inc. cigars) per month in the last 12 months
- current use of central nervous system (CNS) depressants including; other opioids, sedatie/hypnotics, phenothiazines, tranquillisers, skeletal muscle relaxants or sedating antihistamines
- use of macrolide antibiotics (eg. erythromyc), azole antifungal agents (eg. ketoconazole) or protease inhibitors (eg. ritanovir) within 30 days of study dosing
- evidence of clinically relevant oral, cardiovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorders
- history of epilepsy
- history of coronary diseases, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease eg. hypertension where blood pressure (BP) is persistently > 140/95 mmHg
- Any pre-existing medical conditions predisposing the subject to hypoventilation or hypoxaemia
- Known allergy or hypersensitivity to Tegaderm (R) patches or to topical preparations, such as sunscreens
- A calculated creatinine clearance (CL) of equal to or less than 85 ml/min
- Positive screening test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen or hepatitis C antibody
- Use of any prescription medication during the 14 days prior to study dosing, unless approved by both the principal investigator and the sponsor. If necessary, paracetamol (acetaminophen) may be received for mild analgesia prior to, or during, the study
- Use of any over the counter product, herbal product, diet aid, hormone supplement, etc., within 14 days prior to dosing unless approved by both the principal investigator and sponsor
- Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing, other than subjects who undertook the naltrexone challenge successfully as alternates for earlier cohorts of this study
- blood donation of greater than 550 ml within 90 days before the first dose administration
- have a history of low blood pressure or severe motion sickness eg. hypotension where blood pressure is persistently less than 90/50 mmHg
- Consumption of a grapefruit juice within 14 days prior to the first day of study confinement and through to completion of the confinement period
- Regularly drink more than four units of alcohol daily or who may have difficulty abstaining from alcohol during the 36 hours prior to dose administration and until completion of blood sampling.

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)
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
23/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243821 0
Commercial sector/Industry
Name [1] 243821 0
Phosphagenics Limited
Country [1] 243821 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 237171 0
None
Name [1] 237171 0
Address [1] 237171 0
Country [1] 237171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243950 0
Ethics committee address [1] 243950 0
Ethics committee country [1] 243950 0
Date submitted for ethics approval [1] 243950 0
07/10/2009
Approval date [1] 243950 0
Ethics approval number [1] 243950 0

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

Contacts
Principal investigator
Name 30343 0
Address 30343 0
Country 30343 0
Phone 30343 0
Fax 30343 0
Email 30343 0
Contact person for public queries
Name 13590 0
Yelda Ogru
Address 13590 0
11 Duerdin Street
Clayton VIC 3168
Country 13590 0
Australia
Phone 13590 0
+61 3 9565 1156
Fax 13590 0
+61 3 9565 1151
Email 13590 0
[email protected]
Contact person for scientific queries
Name 4518 0
Yelda Ogru
Address 4518 0
11 Duerdin Street
Clayton VIC 3168
Country 4518 0
Australia
Phone 4518 0
+61 3 9565 1156
Fax 4518 0
+61 3 9565 1151
Email 4518 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.