TELESTAR

STUDY OVERVIEW

LX1606.301 is a Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients with Carcinoid Syndrome (CS) Refractory to Somatostatin Analog (SSA) Therapy.

The purpose of the study is to confirm that telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) averaged over the 12-week Treatment Period (12 weeks) of the trial in patient’s refractory to current SSA therapy. (Refractory is defined as having an average of 4 or more BM/day.)

The study will also assess the effects of telotristat etiprate versus placebo over the 12 week Treatment Period to assess:

• improvement in stool consistency
• decreases in number of cutaneous flushing episodes
• decreases in abdominal pain

The study will recruit approximately 120 patients and will be conducted in the US, Canada, UK, Germany, France, Spain, Sweden, Belgium, Ukraine, Italy, Netherlands, and Australia.

The study information provided here is a portion of what is available on ClinicalTrials.gov. For complete information about this and other clinical trials, please click here:
ClinicalTrials.gov