A study to compare the preference of two contrasting paracetamol formulations in the management of osteoarthritis pain

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000565448

Enrollment

260

Registered

2007-11-01

Start date

2007-11-01

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

Brief summary

Paracetamol is first-line pain management for osteoarthrits and this study is designed to investigate patient preference for sustained release paracetamol given 3xdaily compared with standard paracetamol tablet given 4xdaily.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

45 Years to -2147483648 No limit

Healthy volunteers

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

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

Outcome results