Baseline and change from baseline to day 10, week 7 and week 13 in WOMAC osteoarthritis index scale points—intention-to-treat dataset
| Paracetamol | Ibuprofen | 1 × Combination tablet | 2 × Combination tablet | |
|---|---|---|---|---|
| WOMAC subscale points | ||||
| Pain† | ||||
| Baseline, mean±SD (n) | 43.0±14.9 (221) | 44.0±15.2 (224) | 45.0±16.0 (222) | 42.5±15.7 (224) |
| Change from baseline, mean±SD (n) | ||||
| Day 10 | −10.1±16.3 (188)** | −13.3±17.8 (193) | −12.8±16.7 (201) | −15.0±17.5 (204) |
| Week 7 | −14.7±17.8 (148) | −15.0±19.7 (174) | −17.1±18.8 (161) | −18.0±20.3 (173) |
| Week 13 | −15.9±16.3 (136) | −17.6±19.6 (162) | −16.8±19.0 (151) | −18.3±19.5 (159) |
| Endpoint (LOCF) | −10.8±18.6 (215)** | −13.3±20.7 (217) | −14.7±18.7 (220) | −15.5±20.7 (218) |
| Day 10, least squares mean‡ | 36.6 | 33.5 | 34.2 | 31.3 |
| Day 10 pairwise comparisons of change in baseline for WOMAC pain subscale—primary short-term endpoint (PP dataset) | ||||
| Mean difference‡ | SE | 95% CI | p Value‡ | |
| Two combination tablets vs paracetamol | −5.3 (−5.1) | 1.6 (1.8) | −8.5, –2.1 (−8.5 to −1.6) | 0.0012** (0.0040**) |
| One combination tablet vs paracetamol | −2.4 (−2.7) | 1.6 (1.8) | −5.7, 0.8 (−6.2 to 0.8) | 0.1389 (0.1298) |
| Two combination tablets vs ibuprofen | −2.2 (−2.1) | 1.6 (1.7) | −5.4, 1.0 (−5.5 to 1.3) | 0.1787 (0.2331) |
| One combination tablet vs ibuprofen | 0.7 (0.3) | 1.6 (1.8) | −2.5, 3.9 (−3.1 to 3.8) | 0.6772 (0.8621) |
| Two combination tablets vs one combination tablet | −2.9 (−3.0) | 1.6 (1.8) | −6.0, 0.3 (−6.5 to 0.5) | 0.0756 (0.0940) |
| Physical function† | ||||
| Baseline, mean±SD (n) | 42.7±18.9 (219) | 42.8±18.5 (220) | 43.1±19.7 (218) | 41.6±19.1 (223) |
| Change from baseline, mean±SD (n) | ||||
| Day 10 | −8.3±15.5 (186)*** | −10.8±14.3 (186) | −10.3±14.8 (194)* | −13.1±16.5 (203) |
| Week 7 | −11.2±16.8 (145)* | −13.1±17.0 (170) | −14.1±16.2 (154) | −16.0±19.1 (171) |
| Week 13 | −12.7±17.2 (133) | −13.0±17.1 (158) | −13.4±18.2 (144) | −14.5±18.5 (156) |
| Endpoint (LOCF) | −9.2±17.8 (211)* | −10.5±17.8 (213) | −10.9±17.4 (216) | −12.5±18.8 (217) |
| Stiffness† | ||||
| Baseline, mean±SD (n) | 51.4±21.0 (221) | 54.4±19.8 (223) | 54.1±22.4 (221) | 52.4±21.7 (223) |
| Change from baseline, mean±SD (n) | ||||
| Day 10 | −10.7±20.5 (194)*** | −17.3±20.8 (193) | −16.4±21.1 (202) | −18.3±21.2 (206) |
| Week 7 | −16.4±21.7 (147)* | −20.8±21.9 (174) | −21.7±24.1 (160) | −23.1±23.6 (173) |
| Week 13 | −17.0±23.3 (135)* | −22.6±22.8 (161) | −22.0±25.9 (152) | −23.3±25.6 (159) |
| Endpoint (LOCF) | −12.8±23.7 (218)** | −17.2±24.0 (217) | −18.2±25.1 (219) | −19.4±25.8 (217) |
| Composite score† | ||||
| Baseline, mean±SD (n) | 43.5±16.9 (221) | 44.1±16.6 (222) | 44.2±17.9 (222) | 42.7±17.4 (224) |
| Change from baseline, mean±SD (n) | ||||
| Day 10 | −8.9±14.9 (190)*** | −12.0±14.4 (189) | −11.4±14.3 (201)* | −13.9±16.0 (204) |
| Week 7 | −12.5±15.8 (147)* | −14.3±16.8 (172) | −15.0±16.0 (160) | −17.0±18.6 (173) |
| Week 13 | −13.8±16.0 (135) | −15.2±17.1 (161) | −14.6±17.5 (150) | −16.1±18.0 (160) |
| Endpoint (LOCF) | −9.8±17.2 (215)* | −11.9±17.8 (215) | −12.2±16.8 (220) | −13.7±18.7 (218) |
↵* p<0.05,
↵** p<0.01,
↵*** p<0.001 versus two tablets of the fixed-dose tablet combination ibuprofen 200 mg/paracetamol 500 mg tablet.
↵† Normalised to 0–100 mm scale, lower score favourable.
↵‡ Estimated from analysis of covariance model with factors for treatment, presence of osteoarthritis and site and a covariate for baseline WOMAC score.
ITT, intention-to-treat; LOCF, last recorded post-baseline value; PP, per protocol; WOMAC, Western Ontario McMaster Universities osteoarthritis index.