Results of functional, patient based and quality of life efficacy endpoints—intention-to-treat dataset
| Paracetamol | Ibuprofen | 1 × Combination tablet | 2 × Combination tablet | |
|---|---|---|---|---|
| Sit-to-stand test, seconds, mean±SD (n) | ||||
| Baseline | 21.4±33.8 (209) | 20.5±33.2 (218) | 19.4±11.2 (210) | 21.8±61.5 (215) |
| Day 10 | 16.7±9.5 (176)* | 16.3±6.6 (183) | 16.5±6.8 (191) | 14.9±5.6 (203) |
| Week 7 | 15.6±8.5 (139) | 15.3±5.9 (168) | 15.3±6.0 (152) | 14.1±6.2 (171) |
| Week 13 | 15.3±7.7 (124)* | 15.4±5.9 (158)* | 15.2±5.9 (142)* | 13.7±5.1 (154) |
| Endpoint (LOCF) | 16.7±9.4 (199)** | 15.7±6.5 (208) | 16.0±7.1 (204) | 14.5±6.0 (207) |
| Acceptability of knee pain in last 48 h, number reporting yes to acceptability question (n) | ||||
| Baseline | 80, 36.0% (222) | 83, 37.1% (224) | 71, 32.0% (222) | 85, 37.9% (224) |
| Day 10 | 119, 61.0% (195)** | 125, 64.1% (195) | 115, 56.7% (203)** | 151, 73.7% (205) |
| Week 7 | 108, 72.5% (149) | 118, 67.8% (174) | 109, 69.0% (158) | 133, 75.1% (177) |
| Week 13 | 95, 70.9% (134) | 113, 70.6% (160) | 116, 76.3% (152) | 119, 74.4% (160) |
| Endpoint (LOCF) | 138, 63.0% (219) | 139, 64.1% (217) | 141, 64.1% (220) | 144, 65.5% (220) |
| Patient global assessment†, patients rating treatment as excellent or good, n/N (%) | ||||
| Day 10 | 74/194 (38.1)*** | 106/194 (54.6) | 110/204 (53.9) | 127/207 (61.4) |
| Week 7 | 81/149 (54.4)* | 100/176 (56.8) | 96/161 (59.6) | 119/178 (66.9) |
| Week 13 | 74/136 (54.4)** | 93/161 (57.8) | 93/153 (60.8) | 107/160 (66.9) |
| At endpoint (LOCF) | 100/220 (45.5)*** | 111/219 (50.7) | 119/220 (54.1) | 133/221 (60.2) |
| Endpoint (LOCF) least squares means‡ | 2.97 | 2.68 | 2.69 | 2.54 |
| Pairwise comparisons of patient global assessment at study endpoint—primary long-term endpoint | ||||
| Mean difference‡ | SE | 95% CI | p Value‡ | |
| Two combination tablets vs paracetamol | −0.43 | 0.12 | −0.66 to −0.20 | 0.0002 |
| One combination tablet vs paracetamol | −0.28 | 0.12 | −0.51 to −0.05 | 0.0152 |
| Two combination tablets vs ibuprofen | −0.14 | 0.12 | −0.37 to 0.09 | 0.2243 |
| One combination tablet vs ibuprofen | 0.01 | 0.12 | −0.22 to 0.24 | 0.9539 |
↵* p<0.05,
↵** p<0.01,
↵*** p<0.001 versus two tablets of the fixed-dose tablet combination ibuprofen/paracetamol.
↵† Measured on a five-point scale where 1 is excellent, 2 is good, 3 is fair, 4 is poor, 5 is unacceptable.
↵‡ Estimated from analysis of covariance model with factors for treatment, presence of osteoarthritis and site and a covariate for baseline WOMAC score.
LOCF, last recorded post-baseline value; WOMAC, Western Ontario McMaster Universities Osteoarthritis Index.