Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000836235
Ethics application status
Approved
Date submitted
22/07/2009
Date registered
25/09/2009
Date last updated
21/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase I study to determine the tolerability and safety of transdermally delivered oxycodone in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM).
Scientific title
A phase I study in healthy males to determine the tolerability and safety of transdermally delivered oxycodone in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM).
Secondary ID [1] 251734 0
POH015-09
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. 237333 0
Condition category
Condition code
Anaesthesiology 252096 252096 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consists of three test groups.
1. A gel mixture containing of 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone;
2. A reservoir patch system containing 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone and;
3. 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 (or comparator) treatments.
Those allocated to the above groups will receive a total of 200mg Oxycodone applied topically to the upper thigh area once for a 72 hour period.
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] 236996 0
Treatment: Drugs
Comparator / control treatment
20 mg Oxycontin tablet to be taken orally once.
Control group
Active

Outcomes
Primary outcome [1] 238431 0
To evaluate the tolerability and safety of oxycodone in novel formulations containing TPM.
This will be assessed by regular vital sign checks, and participants will be asked if they are experiencing any Adverse Events throughout the duration of the study.
Some adverse events that may be associated with the study drug include; confusion, dizziness, drowsiness, restlessness, mood changes, impaired breathing, decreased frequency in passing urine and decreased urine volume, abdominal pain, constipation, loss of appetite, dry mouth, vomiting, headache, sweating, flushing, itching of skin, pupil constriction, slow heart rate, low blood pressure, faintness and in severe cases circulatory failure and respiratory and cardiac arrest.
Timepoint [1] 238431 0
During Screening, Dosing Period and Follow-Up visit (10-14 days after participant has checked out from clinic).
This outcome will be monitored continuously throughout the entire duration of the study.
Secondary outcome [1] 244932 0
To compare the relative bioavailability of a gel, reservoir and matrix system containing TPM compared to a commercially available tablet.
This will be assessed through blood and urine sampling/analyses.
Timepoint [1] 244932 0
Blood samples will be collected within 15 minutes prior to dosing (0hr) and at the following times thereafter for groups 1, 2 and 3: 0, 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 82, 94, 106, 118, 130, 142 and 154 hours post-dose. For group 4 blood samples will be collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 50, 52, 54, 56, 60, 64, 72 and 96 hours post-dose. A maximum of 29 blood samples will be collected from each subject during the entire study.

10mL samples of every urinary output will be collected, including a pre-dose sample, and the total urine volume at each urinary output will be recorded.

Eligibility
Key inclusion criteria
- Body Mass Index (BMI) must be greater than or equal to 19 and less than or equal to 30 kg/m2.
- Weight must be greater than 50kg
Minimum age
18 Years
Maximum age
49 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History or evidence of drug and/or alcohol abuse; smokers; use of central nervous system (CNS) depressants, other opioids, sedative/hypnotics, phenothiazines, tranquillisers, skeletal muscle relaxants or sedating antihistamines; use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., 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, coronary disease, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack; uncontrolled hypertension or signs/symptoms of ischaemic heart disease; Any pre-existing medical conditions predisposing the subject to hypoventilation or hypoxaemia; Known allergy or hypersensitivity reactions to naltrexone or to oxycodone, or other opioid analgesics (codeine, fentanyl, hydrocodone, morphine etc.), or allergy to any contents of the gel (i.e., disodium tocopheryl phosphate (TP), sodium di-tocopheryl phosphate (T2P), pemulen gel, triethanolamine, methylparaben); Known allergy or hypersensitivity to lidocaine or Tegaderm(registered trademark) patches or to topical preparations, such as sunscreens; A calculated creatinine clearance (CL) of < 85ml/min; Positive screening test for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibody; Have a history of low blood pressure (BP) or severe motion sickness e.g., hypotension where BP is persistently < 90/50 mmHg; Consumption of grapefruit or grapefruit juice within 14 days prior to the first day of study confinement and through to completion of the confinement period.

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
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
3/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237380 0
Commercial sector/Industry
Name [1] 237380 0
Phosphagenics Limited
Country [1] 237380 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street
Clayton VIC
3168
Country
Australia
Secondary sponsor category [1] 236880 0
None
Name [1] 236880 0
Address [1] 236880 0
Country [1] 236880 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 29949 0
Address 29949 0
Country 29949 0
Phone 29949 0
Fax 29949 0
Email 29949 0
Contact person for public queries
Name 13196 0
Yelda Ogru
Address 13196 0
Phosphagenics Limited
11 Duerdin Street
Clayton VIC
3168
Country 13196 0
Australia
Phone 13196 0
+61 3 9565 1156
Fax 13196 0
+61 3 9565 1151
Email 13196 0
[email protected]
Contact person for scientific queries
Name 4124 0
Yelda Ogru
Address 4124 0
Phosphagenics Limited
11 Duerdin Street
Clayton VIC
3168
Country 4124 0
Australia
Phone 4124 0
+61 3 9565 1156
Fax 4124 0
+61 3 9565 1151
Email 4124 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.