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Abstract
The trial is a multi-center, double-blind, randomized, placebo-controlled, parallel designed trial to assess the efficacy and safety of Tectin(TM) for inadequately controlled, moderate to severe cancer-related pain. The interim analysis was performed after 73 patients (half the projected total patient sample size) were enrolled and completed the study. The primary objective of the DMC was to evaluate the unblended results on the primary efficacy outcome, review the safety data and make recommendation to the trial sponsor regarding continuation or early termination of the study based on a conditional power approach. The DMC did not have any serious concern about the safety profile of Tectin(TM). The results of the primary efficacy outcomes demonstrated unfavourable results leading to the recommendation to terminate the current Phase IIb/III trial.