Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000476639
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
23/09/2005
Date last updated
11/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Individual Medication Effectiveness Tests Comparing Celecoxib (encapsulated Celebrex) with Panadol Extend for Relief of Osteoarthritis.
Scientific title
Individual Medication Effectiveness Tests Comparing Celecoxib (encapsulated Celebrex) with Panadol Extend for Relief of Osteoarthritis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 597 0
Condition category
Condition code
Musculoskeletal 670 670 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This single patient (n of 1) Individualised Medication Effectiveness Test (IMET) is a randomised, double-blind, cross-over comparison of celecoxib (200mg ro 400mg daily) and Panadol Extend (3990mg paracetamol daily) within an individual patient. The patient will undergo three pairs of treatment periods. The duration of each treatment period will be two weeks (so each pair will be four weeks), making a total of twelve weeks. During one period of each pair the patient will take celecoxib and a Panadol Extend placebo, and during the other period they will take Panadol Extend and a celecoxib placebo. The order of drugs in each cycle will be determined by random allocation. The choice of initial therapy will be balanced in blocks of four, to ensure that equivalent numbers start the IMET on each of the two drugs. Patient and practitioners will be blinded to which treatment the patients are taking.

The patient will keep careful track of their symptoms by recording them in a special diary. If at any time during the patient feels worse, that treatment period can be terminated, and they can go on to the next treatment period.

Upon the completion of the study, the timing of each active treatment will be revealed. After looking at the symptom scores recorded on the patient's report and the analysis provided by the IMET Service, the doctor and patient decide together which drug is of greatest benefit. If the patient chooses, they can then continue on that drug, confident that it is the most effective.
Intervention code [1] 621 0
Treatment: Drugs
Comparator / control treatment
Panadol Extend Placebo
Control group
Active

Outcomes
Primary outcome [1] 797 0
Identification of non-responders to chronic therapy through routine Individual Medication Effectiveness Tests (IMETs) can reduce adverse events, unnecessary drug therapy and drug expenditure while maintaining benefits to responders. Participants will be asked to consent to follow-up of PBS prescribing (via the HIC) and will be contacted regarding their medication regime. IMETs are resource intensive and their cost effectiveness varies across drugs and patients. This project will evaluate the economic feasibility of routine IMETs. The detailed resource use and outcome data collected nationally will be used to inform: a protocol for cost-effective targeting and administration of such trials; and a business case to inform policy makers.
Timepoint [1] 797 0
Participants will be asked to consent to follow-up of PBS prescribing (via the HIC) and will be contacted regarding their medication regime at 3, 6, 9, and 12 months post-IMET.
Secondary outcome [1] 1617 0
To facilitate the best outcome for the health needs of patients with certain chronic conditions, by allowing doctors to obtain a deeper understanding of what these health needs are and therefore to prescribe appropriately.
Timepoint [1] 1617 0

Eligibility
Key inclusion criteria
Any adult patient with a clinical diagnosis of osteoarthritis with pain of at least a month's duration, of sufficient severity to warranty consideration of long-term Cox-2 inhibitor or paracetamol use, in the opinion of the attending medical practioner. - Either the attending medical practitioner or the patient is uncertain of the effectiveness of their medication for osteoarthritis.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous sensitivity to cox-2 inhibitors, paracetamol, or aspirin- Any patient with contraindications to prescribing of celecoxib or paracetamol- Presence of concomitant disease which will increase the risk of side-effects- Treatment with corticosteroids by joint injection within the previous two months.

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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/12/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
59
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 738 0
Government body
Name [1] 738 0
Australian Health Ministers' Advisory Council
Country [1] 738 0
Australia
Funding source category [2] 739 0
Commercial sector/Industry
Name [2] 739 0
GlaxoSmithKline
Country [2] 739 0
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 612 0
Commercial sector/Industry
Name [1] 612 0
GlaxoSmithKline
Address [1] 612 0
Country [1] 612 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1933 0
University of Queensland
Ethics committee address [1] 1933 0
Ethics committee country [1] 1933 0
Australia
Date submitted for ethics approval [1] 1933 0
Approval date [1] 1933 0
Ethics approval number [1] 1933 0

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

Contacts
Principal investigator
Name 36156 0
Address 36156 0
Country 36156 0
Phone 36156 0
Fax 36156 0
Email 36156 0
Contact person for public queries
Name 9810 0
Norma McNairn
Address 9810 0
Individualised Medication Effectiveness Test (IMET) Service
University of Queensland
Level 2 Edith Cavell Building
Herston QLD 4006
Country 9810 0
Australia
Phone 9810 0
+61 7 33464835
Fax 9810 0
+61 7 33655130
Email 9810 0
[email protected]
Contact person for scientific queries
Name 738 0
Associate Professor Michael Yelland
Address 738 0
Department of Primary Health Care
School of Medicine
Griffith University
Logan Campus
University Drive
Meadowbrook QLD 4131
Country 738 0
Australia
Phone 738 0
+61 7 33821358
Fax 738 0
+61 7 33821338
Email 738 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.