Duration: the studies were of relatively short duration (15 days or less). Medications for chronic pain can be assumed to have use that extends over months and years. Longer clinical trials are, therefore, essential to exclude a transient effect and to investigate such issues as tachyphylaxis, tolerance, dependence and safety. It is recommended that trials investigating therapies for chronic pain have duration of at least 12 weeks. Ethnicity: all participants were Caucasian (except for one or two of African descent). Opioids are generally accepted as being ethnically sensitive, with genetic polymorphisms resulting in different responses in different ethnic populations. Although over 90% of the Australian population has Caucasian ancestry there are other ethnic groups represented, including Aboriginal and Torres Strait Islanders (2.5%), Chinese (4%) and Indian (2%). Age: only adults were included, although the elderly were not excluded. Special populations: patients with any major organ disease were excluded from the studies. Concomitant disease was, however, common. Use of opioids: the majority of study participants had previously used opioids, for both tumour related and non-tumour related pain. The use of opioids for non-tumour pain such as osteoarthritis would be unusual in Australia. Table 12: Results for the primary outcome measure (response rate) Treatment Response Rate (%) 95% Confidence Interval WIS-BUP01 placebo 31.4 16.9 49.3 – 20 mg patch 34.3 19.1 52.2 – 30 mg patch 36.6 22.1 53.1 – 40 mg patch 50.0 33.4 66.6 – WIS-BUP02 placebo 16.2 6.2 32.0 – 20 mg patch 36.6 21.2 53.1 – 30 mg patch 47.5 31.5 63.9 – 40 mg patch 33.3 18.6 51.0 – WIS-BUP03 Placebo 46.7 31.7 62.1 – 30 mg patch 57.5 46.4 68.0 – As shown by the response rates (and 95% confidence interval (CI)) above, none of the three randomised double blind placebo controlled studies (WIS-BUP01, ‘pivotal’ WISBUP02 and WIS-BUP03) were able to show that the patch was significantly better than
Duration: the studies were of relatively short duration (15 days or less). Medications for chronic pain can be assumed to have use that extends over months and years. Longer clinical trials are, therefore, essential to exclude a transient effect and to investigate such issues as tachyphylaxis, tolerance, dependence and safety. It is recommended that trials investigating therapies for chronic pain have duration of at least 12 weeks. Ethnicity: all participants were Caucasian (except for one or two of African descent). Opioids are generally accepted as being ethnically sensitive, with genetic polymorphisms resulting in different responses in different ethnic populations. Although over 90% of the Australian population has Caucasian ancestry there are other ethnic groups represented, including Aboriginal and Torres Strait Islanders (2.5%), Chinese (4%) and Indian (2%). Age: only adults were included, although the elderly were not excluded. Special populations: patients with any major organ disease were excluded from the studies. Concomitant disease was, however, common. Use of opioids: the majority of study participants had previously used opioids, for both tumour related and non-tumour related pain. The use of opioids for non-tumour pain such as osteoarthritis would be unusual in Australia. Table 12: Results for the primary outcome measure (response rate) Treatment Response Rate (%) 95% Confidence Interval WIS-BUP01 placebo 31.4 16.9 – 49.3 20 mg patch 34.3 19.1 – 52.2 30 mg patch 36.6 22.1 – 53.1 40 mg patch 50.0 33.4 – 66.6 WIS-BUP02 placebo 16.2 6.2 – 32.0 20 mg patch 36.6 21.2 – 53.1 30 mg patch 47.5 31.5 – 63.9 40 mg patch 33.3 18.6 – 51.0 WIS-BUP03 Placebo 46.7 31.7 – 62.1 30 mg patch 57.5 46.4 – 68.0 As shown by the response rates (and 95% confidence interval (CI)) above, none of the three ‘pivotal’ randomised double blind placebo controlled studies (WIS-BUP01, WISBUP02 and WIS-BUP03) were able to show that the patch was significantly better than
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