In a comparative, double-blind, between-patient, multicentre trial of 2 weeks' duration the efficacy and tolerability of diclofenac sodium 100 mg slow-release tablets, given either as a morning or an evening dose, were compared with that of diclofenac 50 mg enteric-coated tablets b.i.d. and placebo in 148 patients suffering from osteoarthrosis. Statistically significant differences in efficacy were shown between the two diclofenac slow-release regimes and placebo. Diclofenac 100 mg slow-release taken as a morning or an evening dose tended to be more effective than 50 mg enteric-coated tablets in a twice daily regime. The tolerability of diclofenac 100 mg slow-release and 50 mg enteric-coated b.i.d. regimes was similar and not statistically significantly different from placebo.
SUMMARY In the interests of the safety of patients it is necessary to collect long-term clinical data. It is often assumed that the longer the trial the better. However, the longer the trial the more scientific compromises are necessary if it is to be carried out in a practical way. Because the therapeutic efficacy of and tolerance to the nonsteroidal anti-inflammatory drug diclofenac was established after 6 months' trial the optimal duration for a comparative long-term trial of this preparation is 6 months. The small amount of information gained from trials of diclofenac longer than this did not justify the reduction in quality of trial design and performance that they required. Thus it would appear that at least for 1 antirheumatic drug the assumption that 'the longer the trial the better' is not true.
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