Trial Review

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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.
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Duchenne muscular dystrophy 153 0
Condition category
Condition code
Musculoskeletal 172 172 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-month trial of steroids plus Oxpentifylline as an add on treatment
Intervention code [1] 65 0
Treatment: Drugs
Comparator / control treatment
Steroids + placebo
Control group
Placebo

Outcomes
Primary outcome [1] 211 0
Muscle strength
Timepoint [1] 211 0
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.
Secondary outcome [1] 480 0
Assessment for changes in inflammation and muscle fibrosis.
Timepoint [1] 480 0
At the start of the trial, and after the conclusion of the trial (12 months after starting Oxpentifylline or placebo).

Eligibility
Key inclusion criteria
Duchenne muscular dystrophy, ambulant, stable dose of steroids for 12 months.
Minimum age
7 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)
Randomised by coordinating centre pharmacy
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 227 0
Other
Name [1] 227 0
Institute for Neuromuscular Research
Country [1] 227 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Country
Australia
Secondary sponsor category [1] 170 0
Other Collaborative groups
Name [1] 170 0
Cooperative International Neuromuscular Research Group
Address [1] 170 0
Country [1] 170 0
United States of America

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36321 0
Address 36321 0
Country 36321 0
Phone 36321 0
Fax 36321 0
Email 36321 0
Contact person for public queries
Name 9254 0
Sian Rudge
Address 9254 0
Clinical Sciences
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 9254 0
Australia
Phone 9254 0
+61 2 98451229
Fax 9254 0
+61 2 98451317
Email 9254 0
sianr@chw.edu.au
Contact person for scientific queries
Name 182 0
Sian Rudge
Address 182 0
Clinical Sciences
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 182 0
Australia
Phone 182 0
+61 2 98451229
Fax 182 0
+61 2 98451317
Email 182 0
sianr@chw.edu.au

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.