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Trial registered on ANZCTR


Registration number
ACTRN12605000526673
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 compare the bioavailability and pharmacokinetics of fentanyl after administration of a single dose of a Fentanyl MDTS and a Durogesic 25 patch in pain
Scientific title
A phase I study to compare the bioavailability and pharmacokinetics of fentanyl after administration of a single dose of a Fentanyl MDTS and a Durogesic 25 patch in pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 651 0
Condition category
Condition code
Other 724 724 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 Durogesic 25 patch for single dose, Naltrexone daily for three days.
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 886 0
Pharmacokinetic parameters
Timepoint [1] 886 0
On days 1 - 4
Secondary outcome [1] 1750 0
Safety and Tolerability
Timepoint [1] 1750 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
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] 805 0
Commercial sector/Industry
Name [1] 805 0
Acrux DDS Pty Ltd
Address [1] 805 0
Country [1] 805 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Acrux DDS Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 664 0
None
Name [1] 664 0
None
Address [1] 664 0
Country [1] 664 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36068 0
Address 36068 0
Country 36068 0
Phone 36068 0
Fax 36068 0
Email 36068 0
Contact person for public queries
Name 9705 0
Karen Gard'ner
Address 9705 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9705 0
Australia
Phone 9705 0
+61 3 83790100
Fax 9705 0
Email 9705 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 633 0
Andrew Humberstone
Address 633 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 633 0
Australia
Phone 633 0
+61 3 83790100
Fax 633 0
Email 633 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