Clinical Trial: Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)

Brief Summary: The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.

Detailed Summary:
Sponsor: Lexicon Pharmaceuticals

Current Primary Outcome: Incidence of treatment-emergent adverse events [ Time Frame: 50 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of Life measures [ Time Frame: Baseline and every 24 weeks ]

EORTC QLQ-C30 (a questionnaire developed to assess the quality of life of cancer patients) and GI.NET21 (module intended for use among patients with G.I.-related neuroendocrine tumours) quality of life questionnaires


Original Secondary Outcome: Same as current

Information By: Lexicon Pharmaceuticals

Dates:
Date Received: December 31, 2013
Date Started: December 2013
Date Completion:
Last Updated: June 2, 2016
Last Verified: June 2016