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Trial registered on ANZCTR


Registration number
ACTRN12605000524695
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 pharmacokinetic phase I study to assess the bioavailability and pharmacokinetics of Fentanyl from a metered dose transdermal system (MDTS) in pain
Scientific title
A pharmacokinetic phase I study to assess the bioavailability and pharmacokinetics of Fentanyl from a metered dose transdermal system (MDTS) in pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 649 0
Condition category
Condition code
Other 722 722 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 metered dose transdermal system (MDTS) and Durogesic patch, single dose two way crossover.
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 884 0
Pharmacokinetic parameters
Timepoint [1] 884 0
On days 1 - 5 of each period
Secondary outcome [1] 1748 0
Safety and Tolerability
Timepoint [1] 1748 0

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
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
Crossover
Other design features
Phase
Phase 1
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] 803 0
Commercial sector/Industry
Name [1] 803 0
Acrux DDS Pty Ltd
Address [1] 803 0
Country [1] 803 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Acrux DDS Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 662 0
None
Name [1] 662 0
None
Address [1] 662 0
Country [1] 662 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35511 0
Address 35511 0
Country 35511 0
Phone 35511 0
Fax 35511 0
Email 35511 0
Contact person for public queries
Name 9702 0
Karen Gard'ner
Address 9702 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9702 0
Australia
Phone 9702 0
+61 3 83790100
Fax 9702 0
Email 9702 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 630 0
Andrew Humberstone
Address 630 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 630 0
Australia
Phone 630 0
+61 3 83790100
Fax 630 0
Email 630 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