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Trial registered on ANZCTR


Registration number
ACTRN12607000565448
Ethics application status
Approved
Date submitted
11/10/2007
Date registered
1/11/2007
Date last updated
29/05/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to compare the preference of two contrasting paracetamol formulations in the management of osteoarthritis pain
Scientific title
A study to compare the preference of two contrasting paracetamol formulations in the management of osteoarthritis pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 2444 0
Condition category
Condition code
Musculoskeletal 2548 2548 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive both treatments. Two weeks treatment with immediate release paracetamol (1000mg four times daily - oral), and two weeks of extended release paracetamol (1330mg three times daily - oral). There is no washout period between the treatments.
Intervention code [1] 2174 0
Treatment: Drugs
Comparator / control treatment
Immediate release paracetamol (1000mg four times daily - oral) for 2 weeks.
Control group
Active

Outcomes
Primary outcome [1] 3453 0
Patient preference for a particular treatment in the management of osteoarthritis pain
Timepoint [1] 3453 0
When patients have completed both 2 week arms of the study.
Secondary outcome [1] 5741 0
Patient satisfaction with treatment using a verbal rating scale.
Timepoint [1] 5741 0
Completed at the end of each 2 week treatment period.
Secondary outcome [2] 5742 0
Patient attitude towards treatment convenience
Timepoint [2] 5742 0
At the end of the study
Secondary outcome [3] 5743 0
Global assessment of response to treatment
Timepoint [3] 5743 0
At the end of each 2 week treatment period
Secondary outcome [4] 5744 0
Overall experience of pain using a verbal rating scale.
Timepoint [4] 5744 0
At the end of each 2 week treatment period
Secondary outcome [5] 5745 0
Quality of sleep during the night
Timepoint [5] 5745 0
At the end of each 2 week treatment period
Secondary outcome [6] 5746 0
Night time disturbance due to knee pain
Timepoint [6] 5746 0
At the end of each 2 week treatment period
Secondary outcome [7] 5747 0
Pain on waking
Timepoint [7] 5747 0
At the end of each 2 week treatment period
Secondary outcome [8] 5748 0
Pain on walking
Timepoint [8] 5748 0
At the end of each 2 week treatment period
Secondary outcome [9] 5749 0
Pain at rest
Timepoint [9] 5749 0
At the end of each 2 week treatment period
Secondary outcome [10] 5750 0
Compliance with medication
Timepoint [10] 5750 0
At the end of each 2 week treatment period

Eligibility
Key inclusion criteria
At least 45 years of age, good general health, diagnosis of osteoarthritis of the knee with the pain worse in one knee, pain must be suitable for treatment with a simple analgesic
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of a secondard cause of osteoarthritis, medical condition that may affect the ability to rate pain, any contraindication to the use of paracetamol or ibuprofen, intra-articular steroid injection to the knees within the last 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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The assignment of the order of study medication will be determined by a computer-generated randomisation schedule.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2695 0
Commercial sector/Industry
Name [1] 2695 0
GlaxoSmithKline Consumer Healthcare
Country [1] 2695 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline Consumer Healthcare
Address
82 Hughes Avenue
Ermington NSW 2072
Country
Australia
Secondary sponsor category [1] 2439 0
None
Name [1] 2439 0
Address [1] 2439 0
Country [1] 2439 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4616 0
Ethics committee address [1] 4616 0
Ethics committee country [1] 4616 0
Date submitted for ethics approval [1] 4616 0
03/10/2007
Approval date [1] 4616 0
Ethics approval number [1] 4616 0

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

Contacts
Principal investigator
Name 28106 0
Address 28106 0
Country 28106 0
Phone 28106 0
Fax 28106 0
Email 28106 0
Contact person for public queries
Name 11263 0
Fiona Dunagan
Address 11263 0
GSK Consumer Healthcare
82 Hughes Avenue
(Locked Bag 3)
Ermington NSW 2113
Country 11263 0
Australia
Phone 11263 0
+61 2 96840888
Fax 11263 0
Email 11263 0
fiona.m.dunagan@gsk.com
Contact person for scientific queries
Name 2191 0
Fiona Dunagan
Address 2191 0
GSK Consumer Healthcare
82 Hughes Avenue
(Locked Bag 3)
Ermington NSW 2113
Country 2191 0
Australia
Phone 2191 0
+61 2 96840888
Fax 2191 0
Email 2191 0
fiona.m.dunagan@gsk.com

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.