ABSTRACT
This example is based on a Phase II Proof of Concept (PoC), placebocontrolled, study that examined the pain relief of a novel drug in subjects with flare enriched osteoarthritis of the knee. The two treatments in the trial were a novel drug (A) and a placebo (P). The design was a 2× 2 cross-over trial, as shown in Table 11.1. The primary endpoint was the Western Ontario and McMaster (WOMAC) Osteoarthritis Index pain subscale score measured at the end of each treatment period. The subscale is the sum of the answers to five questions, where the answer to each question was coded as 0 to 4, giving a maximum total of 20. Each active period lasted two weeks and there was a two-week wash-out period between them. The recorded pain score was subsequently rescaled to lie in the range 0-10, to give the primary endpoint for analysis. Higher scores indicate greater pain.
