OBJECTIVE: To investigate short-term efficacy and safety of a novel lipid ibuprofen formulation 1200mg/day compared with standard ibuprofen 1200mg/day and 2400mg/day in episodic knee arthralgia/flaring pain.
DESIGN: Multicentre, randomised, double-blind, 3-arm, non-inferiority trial conducted at 27 primary care centres. Adults with ≥1 knee flare episode within 12 months were recruited within 24 hours of new flare with pain severity ≥5 on a 0-10 numerical rating scale (NRS). Primary outcome was change from baseline in WOMAC pain subscale over 5 days. Main secondary outcome was Gastrointestinal Symptom Rating Scale (GSRS) change from baseline. Other endpoints included assessment of WOMAC total subscale scores and self-reported NRS for pain, subject nominated activity, stiffness and swelling. RESULTS: 462 patients were enrolled (58.9% males; mean age 52.2 years). Treatment allocation comprised 148 lipid 1200mg, 155 soft-gel 1200mg, 159 soft-gel 2400mg. WOMAC pain subscale scores decreased in all groups, with lipid 1200mg being non-inferior to soft-gel 1200mg (adjusted mean difference -0.26 [95% CI-0.69, 0.17]) and to soft-gel 2400mg (difference 0.19 [95% CI -0.24, 0.62]). No differences were seen in mean GSRS total scores. NRS secondary endpoints suggested greater improvements in the lipid 1200mg group compared to soft-gel 1200mg, with similar results to soft-gel 2400mg. The most frequent drug-related AEs were GI disorders, with statistically fewer events for lipid 1200mg vs soft-gel 2400mg (p=0.01, post-hoc analysis). CONCLUSIONS: Ibuprofen 1200mg/day lipid formulation was non-inferior to standard ibuprofen soft-gel capsules 1200mg and 2400mg/day in relieving flaring knee pain. NRS endpoints showed lipid 1200mg was numerically similar to soft-gel 2400mg.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)