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Trial registered on ANZCTR


Registration number
ACTRN12609000743268
Ethics application status
Approved
Date submitted
25/08/2009
Date registered
26/08/2009
Date last updated
3/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The absorption of fentanyl from a new wafer in patients who have had major surgery
Scientific title
The pharmacokinetics and acceptability of a sublingual fentanyl wafer in postoperative patients who have had major gynaecological surgery
Secondary ID [1] 287745 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 243543 0
Condition category
Condition code
Anaesthesiology 239840 239840 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single administration of sublingual fentanyl wafer 50 mcg and single administration of intravenous fentanyl 50 mcg, in randomised order, with an 18 hour washout period, after major gynaecological surgery among patients having patient-controlled intavenous morphine
Intervention code [1] 241149 0
Treatment: Drugs
Comparator / control treatment
A single control administration of intravenous fentanyl 50 mcg, in randomised order with sublingual fentanyl, with an 18 hour washout period, after major gynaecological surgery among patients having patient-controlled intavenous morphine
Control group
Active

Outcomes
Primary outcome [1] 240607 0
Drug pharmacokinetics based on fentanyl assay in venous blood using Gas Chromatography Mass Spectrometry (GCMS)
Timepoint [1] 240607 0
2,5,10,30,60,120, and 180 minutes post-administration for each route of administration
Secondary outcome [1] 257241 0
Patient acceptability of wafer assessed by questionnaire and verbal numerical rating score 0-10
Timepoint [1] 257241 0
Assessed at 30 minutes post-administration

Eligibility
Key inclusion criteria
Age 18-70 years
Gynaecological surgery
Using intravenous morphine patient -controlled analgesia postoperatively
Minimum age
18 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Oral pathology
Intolerance of opioids
Pregnancy

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)
Preoperative written consent then allocated using sealed envelope according to cross-over randomization sequence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Latin square randomisation for cross-over sequence
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)
WA

Funding & Sponsors
Funding source category [1] 237516 0
Commercial sector/Industry
Name [1] 237516 0
iX Biopharma
Address [1] 237516 0
Vbox 881705
Singapore 919191
Country [1] 237516 0
Singapore
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital for Women
Address
374 Bagot Rd
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 236995 0
None
Name [1] 236995 0
Address [1] 236995 0
Country [1] 236995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243648 0
Women's and Newborn's Health Service
Ethics committee address [1] 243648 0
Ethics committee country [1] 243648 0
Australia
Date submitted for ethics approval [1] 243648 0
Approval date [1] 243648 0
07/07/2009
Ethics approval number [1] 243648 0
1700/EW

Summary
Brief summary
The pharmacokinetics of a new formulation of fentanyl citrate are being evaluated in postoperative patients
Trial website
Trial related presentations / publications
Lim CB, Paech MJ, Sunderland B, Liu Y. In vitro and in vivo evaluation of a sublingual fentanyl wafer formulation. Drug Res Develop Ther 2013;7:317-24
Public notes

Contacts
Principal investigator
Name 29876 0
Mr Chin Beng (Stephen) Lim
Address 29876 0
Pharmacy Department, PO Box 460 Armadale 6992 Western Australia, Australia
Country 29876 0
Australia
Phone 29876 0
+61 8 93343722
Fax 29876 0
Email 29876 0
Stephen.Lim@health.wa.gov.au
Contact person for public queries
Name 13123 0
Mr Chin Beng (Stephen) Lim
Address 13123 0
Pharmacy Department
PO Box 460
Armadale
6992
Country 13123 0
Australia
Phone 13123 0
+61 8 93343722
Fax 13123 0
Email 13123 0
Stephen.Lim@health.wa.gov.au
Contact person for scientific queries
Name 4051 0
Mr Chin Beng (Stephen) Lim
Address 4051 0
Pharmacy Department
PO Box 460
Armadale
6992
Country 4051 0
Australia
Phone 4051 0
+61 8 93343722
Fax 4051 0
Email 4051 0
Stephen.Lim@health.wa.gov.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