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Trial registered on ANZCTR


Registration number
ACTRN12609001020279
Ethics application status
Not yet submitted
Date submitted
23/11/2009
Date registered
24/11/2009
Date last updated
4/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Exelon Patch (Transdermal Rivastigmine) for the treatment of severe delirium in elderly subacute care inpatients
Scientific title
A double blinded randomised placebo controlled trial of the exelon patch (transdermal rivastigmine) for the treatment of severe delirium in elderly subacute care inpatients.
Secondary ID [1] 1147 0
None
Universal Trial Number (UTN)
U1111-1112-5952
Trial acronym
EPFD1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium in elderly subacute care inpatients 252255 0
Condition category
Condition code
Neurological 252444 252444 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transdermal Rivastigmine 4.6mg/hour patch applied topically changed daily for two weeks.
Intervention code [1] 241586 0
Treatment: Drugs
Comparator / control treatment
Placebo; Placebo patch identical in appearance to the Transdermal Rivastigmine, without the active ingredient, applied topically and changed daily for two weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 253316 0
Peak Delirium Severity on Delirium Rating Scale.
Timepoint [1] 253316 0
week two of treatment
Secondary outcome [1] 262389 0
nil
Timepoint [1] 262389 0
nil

Eligibility
Key inclusion criteria
Severe Delirium (Confusion assessment method positive, delirium rating scale 12 or more)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Informed consent unable to be obtained
Deficits in cardiac conducting system, resting pulse <50, intolerance or allergy to rivastigmine, carbamates or excipients.
Severe dysphasia, visual or hearing impairment, or non english speaking such that unable to complete scales.
Expected prognosis or discharge less than 2 weeks.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
7/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2257 0
3050

Funding & Sponsors
Funding source category [1] 244068 0
Commercial sector/Industry
Name [1] 244068 0
Novartis Pharmaceutical Australia Pty Ltd
Country [1] 244068 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Grattan street
THE ROYAL MELBOURNE HOSPITAL
VIC 3050
Country
Australia
Secondary sponsor category [1] 251414 0
None
Name [1] 251414 0
Address [1] 251414 0
Country [1] 251414 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258166 0
Melbourne Health Human Research and Ethics Committee.
Ethics committee address [1] 258166 0
Ethics committee country [1] 258166 0
Australia
Date submitted for ethics approval [1] 258166 0
19/09/2009
Approval date [1] 258166 0
Ethics approval number [1] 258166 0
2009.147

Summary
Brief summary
Acetylcholine levels are decreased in delirium, a condition of a sudden change in mental capacity occurring due to a illness, medication or similar insult. Rivastigmine is a medication for Alzhiemer's Disease, another condition where there is a change in mental capacity and low levels of acetylcholine. It increases levels of acetylcholine in the brain. THis trial aims to determine if a rivastigmine patch given to elderly patients in hospital after their illness has resolved but who still have delirium will have a less severe delirium.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30538 0
Dr Peter Lange
Address 30538 0
c/o APU Ground Floor the Royal Melbourne Hospital Grattan Street THE ROYAL MELBOURNE HOSPITAL VIC 3050 Australia
Country 30538 0
Australia
Phone 30538 0
+61039342835
Fax 30538 0
Email 30538 0
[email protected]
Contact person for public queries
Name 13785 0
Dr Peter Lange
Address 13785 0
National Ageing Research Institute
PO Box 2127, Royal Melbourne Hospital,
Carlton, Victoria 3050
Country 13785 0
Australia
Phone 13785 0
+61 3 9342 7000
Fax 13785 0
Email 13785 0
[email protected]
Contact person for scientific queries
Name 4713 0
Dr Peter Lange
Address 4713 0
National Ageing Research Institute
PO Box 2127, Royal Melbourne Hospital,
Carlton, Victoria 3050
Country 4713 0
Australia
Phone 4713 0
+61 3 93427000
Fax 4713 0
Email 4713 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
SourceTitleYear of PublicationDOI
EmbaseResults from a double blinded, randomised, placebo-controlled, feasibility trial of melatonin for the treatment of delirium in older medical inpatients.2021https://dx.doi.org/10.1111/imj.14763
N.B. These documents automatically identified may not have been verified by the study sponsor.