6 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)
To evaluate the effectiveness of a calcium phosphate mouth rinse (Caphosol) on the burden of disease of moderate and severe oral mucositis (WHO scale grade II-IV). In breast cancer patients receiving FE90C x6 (q3w), FE100C x3 (q3w) followed with…
Trial hypothesisAdding the use of Caphosol® (rinsing and swallowing four times a day) to the standard of care for esophagitis/mucositis, reduces the incidence, onset, duration and severity of esophagitis in (N)SCLC patients, comparing to the…
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…
Primary Objective:To measure distances between the pointer tip held on surgical clips placed on the liver surface and the closest tumor border using navigation, and compare it to the actual distance measured in intraoperative XperCT. Secondary…
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.