Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12612000831886
Ethics application status
Approved
Date submitted
1/08/2012
Date registered
7/08/2012
Date last updated
7/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study to investigate the efficacy of dexamphetamine to treat obesity using dosage titration
Scientific title
A pilot study to investigate the efficacy of dexamphetamine to treat obesity using dosage titration
Secondary ID [1] 280705 0
Nil
Universal Trial Number (UTN)
U1111-1131-9918
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 286743 0
Condition category
Condition code
Diet and Nutrition 287045 287045 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 months treatment with dexamphetamine 5mg oral tablets given twice daily. The dose is increased by weekly increments of 10mg to a maximum of 12 tablets per day (60mg), stopping short of the maximum dose if there are side effects.
Intervention code [1] 285124 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287380 0
Weight loss from baseline (difference between weight in kg at baseline and weight in kg at 3, 6 and 12 months)
Timepoint [1] 287380 0
3, 6 and 12 months
Secondary outcome [1] 298039 0
Maintenance of weight loss, as determined by change in weight (kg) over the 6 months following cessation of treatment
Timepoint [1] 298039 0
12 months

Eligibility
Key inclusion criteria
BMI > 30
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable heart disease
Uncontrolled hypertension
History of addiction to illicit drugs
uncontrolled epilepsy
weight change of +/- 3kg the past 3 months
breastfeeding, pregnant or planning pregnancy
current depression or other psychiatric illness
current or recent treatment (past 12 months) with psychotropic medication, systemic glucocorticoids or medication for weight loss (eg orlistat)
family history of sudden death from cardiac causes

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285474 0
Hospital
Name [1] 285474 0
Nepean Hospital Department of Cardiology Trust Fund
Country [1] 285474 0
Australia
Primary sponsor type
Hospital
Name
Nepean Blue Mountains Local Health District
Address
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Country
Australia
Secondary sponsor category [1] 284327 0
None
Name [1] 284327 0
Address [1] 284327 0
Country [1] 284327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287488 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 287488 0
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Ethics committee country [1] 287488 0
Australia
Date submitted for ethics approval [1] 287488 0
Approval date [1] 287488 0
12/04/2012
Ethics approval number [1] 287488 0
12/3 - HREC/12/NEPEAN/8

Summary
Brief summary
The project is designed to test a) whether dexamphetamine can be used safely to treat adults with obesity, b) whether dexamphetamine is effective for treating obesity over a six month period
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34340 0
Address 34340 0
Country 34340 0
Phone 34340 0
Fax 34340 0
Email 34340 0
Contact person for public queries
Name 17587 0
Dr Alison Poulton
Address 17587 0
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Country 17587 0
Australia
Phone 17587 0
+61 247343366
Fax 17587 0
+61 247341144
Email 17587 0
[email protected]
Contact person for scientific queries
Name 8515 0
Dr Alison Poulton
Address 8515 0
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Country 8515 0
Australia
Phone 8515 0
+61 247343366
Fax 8515 0
+61 247341144
Email 8515 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
No additional documents have been identified.