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Trial registered on ANZCTR
Registration number
ACTRN12605000078651
Ethics application status
Approved
Date submitted
25/07/2005
Date registered
5/08/2005
Date last updated
22/08/2007
Type of registration
Retrospectively registered
Titles & IDs
Public title
A randomized phase III study to evaluate the effects of Oxpentifyllene as an add on therapy for boys with duchenne muscular dystrophy in improving muscle strength and function.
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Scientific title
A randomized phase III study to evaluate the effects of Oxpentifyllene as an add on therapy for boys with duchenne muscular dystrophy in improving muscle strength and function.
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Duchenne muscular dystrophy
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Condition category
Condition code
Musculoskeletal
172
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
12-month trial of steroids plus Oxpentifylline as an add on treatment
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Intervention code [1]
65
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Treatment: Drugs
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Comparator / control treatment
Steroids + placebo
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Muscle strength
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Assessment method [1]
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Timepoint [1]
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Evaluated at the start of the trial (prior to the commencement of treatment drug or placebo), 1 month, 4 months, 8 months and 12 months after starting on the trial.
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Secondary outcome [1]
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Assessment for changes in inflammation and muscle fibrosis.
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Assessment method [1]
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Timepoint [1]
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At the start of the trial, and after the conclusion of the trial (12 months after starting Oxpentifylline or placebo).
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Eligibility
Key inclusion criteria
Duchenne muscular dystrophy, ambulant, stable dose of steroids for 12 months.
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Minimum age
7
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
No exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised by coordinating centre pharmacy
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be accomplished by pre-generating a database of randomly permuted balanced blocks.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/02/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
64
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Other
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Name [1]
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Institute for Neuromuscular Research
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
The Children's Hospital at Westmead
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Address
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Country
Australia
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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Cooperative International Neuromuscular Research Group
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Address [1]
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Country [1]
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United States of America
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
Oxpentifylline is being trialled as an add on drug to steroids - at present the only known med to positively influence DMD. It is thought that it may reduce some of the secondary problems in muscles such as fibrosis and inflammation.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sian Rudge
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Address
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Clinical Sciences
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
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Country
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Australia
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Phone
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+61 2 98451229
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Fax
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+61 2 98451317
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Email
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[email protected]
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Contact person for scientific queries
Name
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Sian Rudge
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Address
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Clinical Sciences
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
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Country
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Australia
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Phone
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+61 2 98451229
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Fax
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+61 2 98451317
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Email
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[email protected]
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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.
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