Telotristat Etiprate for Carcinoid Syndrome Therapy
Trial ID or NCT#
The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.
A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome
- - Patients ≥ 18 years of age - All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit. - Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor - Documented history of carcinoid syndrome - Patient is able and willing to provide written informed consent prior to participation
- - Presence of diarrhea attributed to any condition other than carcinoid syndrome. - Presence of 12 or more watery bowel movements per day - Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening - Karnofsky Performance Status ≤ 60% - Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator - A history of short bowel syndrome - History of constipation within 2 years of Screening - Life expectancy < 12 months from Screening
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