COMPARISON OF THE EFFICACY AND TOLERABILITY OF A PARACETAMOL CODEINE FIXED-DOSE COMBINATION WITH TRAMADOL IN PATIENTS WITH REFRACTORY CHRONIC BACK PAIN/

Fifty-five patients suffering from refractory chronic back pain took p art in a double-blind, multiple-dose, randomised, cross-over study to compare the efficacy and tolerability of a fixed-dose capsule preparat ion containing 500 mg paracetamol (CAS 103-90-2) and 30 mg codeine pho sphate 1/2 H2O (CAS 41444-62-6) (talvosilen(R) forte, test preparation ) with a reference capsule preparation containing 50 mg tramadol hydro chloride (CAS 22204-88-2), in a regimen of two capsules 8-hourly. Ther e were two treatment periods of up to 7 days each. Cross-over took pla ce, without washout, at the end of 7 days, or sooner if patients were unable to tolerate the first treatment. The test preparation was at le ast as efficacious as the reference in the treatment of back pain (81% of patients experienced good or satisfactory pain relief). 81% of pat ients tolerated the test well compared to only 69% receiving the refer ence, as per protocol analysis. The results of this study suggest that the test product is at least as efficacious as tramadol in the treatm ent of patients with refractory chronic back pain, whilst being better tolerated.