5 results
Primary Study Objective: To evaluate the effect of telotristat etiprate versus placebo over the double-blind portion of the study on the incidence of treatment-emergent adverse events (TEAEs)
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the change from baseline in the number of daily bowel movements (BMs) averaged over the 12-week…
The primary objective of the study is to quantitatively determine the PK (distribution, metabolism, and excretion) of 14C-vosaroxin and its metabolites in patients with advanced solid tumors.The secondary objective is to evaluate safety and…
The primary objective of this study is to assess the efficacy of gabapentin as add-on to morphine for the treatment of severe chronic neuropathic or mixed pain in children from 3 months to less than 18 years of age. Secondary objectives 1. To assess…
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.The secondary objective is to evaluate changes in patients* quality of life (QOL) through week 84.