[Double-blind parallel-group dose-titration study comparing a fentanyl-containing patch formulated for 1-day...

The efficacy and safety of a fentanyl-containing patch formulated for 1-day application at the initiation and during continuous treatment of cancer pain were evaluated in patients previously untreated with opioid analgesics.

In the dose-titration period (Period I), the 1-day formulation (0.84 mg x day(-1)) was applied for 2 days. If pain relief was insufficient, the dose was titrated, and the success rate was evaluated. In the double-blind period (Period II), the efficacies of the 1-day and the 3-day formulations for pain control were compared.

The dose-titration success rate of the 1-day formulation was 80.6%, and its analgesic effect was comparable to that of the 3-day formulation. Moreover, tolerability of the 1-day formulation was good. Adverse events occurring in the patients were those generally seen after treatments with opioid analgesics, and severe symptoms were also reported.

Dose titration of the 1-day formulation was accomplished in a short period in patients with cancer pain who had been previously untreated with opioid analgesics; the efficacy of the formulation for pain control after repeated dosing was comparable to that of the 3-day formulation, and its tolerability was good. However, it was considered that the 1-day formulation should be used in patients with good tolerability to opioid analgesics. Further, for safety reasons, the dose should not be increased for at least 2 days after the initial application and the last dose increase.