CompletedPhase 3ACTRN12611000952943

A study comparing the effects of a combination of paracetamol and ibuprofen with paracetamol alone or ibuprofen alone or placebo

Maxi-Analgesic Arthroscopy Study: A double-blind, placebo-controlled, randomised, parallel group comparison of the effects of Maxigesic (paracetamol 1000mg + ibuprofen 300mg per dose) versus its individual components in participants with moderate to severe pain from post arthrsocopy surgery of the knee.

Sponsor

AFT Pharmaceuticals Ltd.

Enrollment

295 participants

Start Date

Oct 31, 2011

Study Type

Interventional

Conditions

Post-operative pain from arthroscopy surgery of the knee

Summary

A Phase 3 study in dental pain has demonstrated efficacy for the fixed-dose combination compared with the individual components(Merry et al. 2010). However an additional model of acute pain is required to demonstrate consistent efficacy in acute pain as per EMEA guidelines required (EMEA/CPMP/EWP/612/00 21 November, 2002). The fixed dose combination has already been approved in New Zealand and is on the market for OTC use. Periodic Safety Update data from the NZ market and also the open –label phase of the Phase II Osteoarthritis study 12 month continuation phase data are available.

Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares a combination of paracetamol and ibuprofen against each drug alone and placebo for pain relief after knee arthroscopy (keyhole surgery to remove damaged cartilage). Adults aged 16-80 with moderate or greater post-operative pain are eligible. The goal is to determine whether the combination provides better pain relief than either medication used individually.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A combination of Paracetamol 500mg + Ibuprofen 150mg per tablet, 2 tablets orally every 6 hours for 24 hours.

Locations(2)

Hamilton, New Zealand

Christchurch, New Zealand

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ACTRN12611000952943