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
ACTRN12605000527662
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
26/09/2005
Date last updated
25/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase I study to investigate the linearity of fentanyl steady-state pharmacokinetics following dose-escalated multiple applications of a Fentanyl MDTS in healthy male volunteers in pain
Scientific title
A phase I study to investigate the linearity of fentanyl steady-state pharmacokinetics following dose-escalated multiple applications of a Fentanyl MDTS in healthy male volunteers in pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 652 0
Condition category
Condition code
Other 725 725 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fentanyl MDTS and Naltrexone for up to 21 days.
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 887 0
Pharmacokinetic parameters
Timepoint [1] 887 0
On days 1 and 21
Secondary outcome [1] 1751 0
Safety and Tolerability
Timepoint [1] 1751 0

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
Not stated
Maximum age
Not stated
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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)
Open label
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated in blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 806 0
Commercial sector/Industry
Name [1] 806 0
Acrux DDS Pty Ltd
Address [1] 806 0
Country [1] 806 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Acrux DDS Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 665 0
None
Name [1] 665 0
None
Address [1] 665 0
Country [1] 665 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35546 0
Address 35546 0
Country 35546 0
Phone 35546 0
Fax 35546 0
Email 35546 0
Contact person for public queries
Name 9710 0
Karen Gard'ner
Address 9710 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9710 0
Australia
Phone 9710 0
+61 3 83790100
Fax 9710 0
Email 9710 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 638 0
Andrew Humberstone
Address 638 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 638 0
Australia
Phone 638 0
+61 3 83790100
Fax 638 0
Email 638 0
andrew.humberstone@acrux.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary