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Individual Medication Effectiveness Tests Comparing Celecoxib (encapsulated Celebrex) with Panadol Extend for Relief of Osteoarthritis.

Individual Medication Effectiveness Tests Comparing Celecoxib (encapsulated Celebrex) with Panadol Extend for Relief of Osteoarthritis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000476639
Enrollment
59
Registered
2005-09-23
Start date
2003-12-07
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 Pan

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.

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026