Clinical Trial: Telotristat Etiprate for Carcinoid Syndrome Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrom

Brief Summary: 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.

Detailed Summary:
Sponsor: Lexicon Pharmaceuticals

Current Primary Outcome:

  • Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ]
  • Percent change from baseline in 24-hour urinary 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: Week 12 ]


Original Primary Outcome: Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ]

Current Secondary Outcome:

  • Change from baseline in the number of daily bowel movements [ Time Frame: 12 weeks ]
  • Change from baseline in stool consistency [ Time Frame: 12 weeks ]
  • Change from baseline in the number of cutaneous flushing episodes [ Time Frame: 12 weeks ]
  • Change from baseline in abdominal pain [ Time Frame: 12 weeks ]
  • Change in the frequency of rescue short-acting, somatostatin analog used to treat carcinoid syndrome symptoms [ Time Frame: 12 weeks ]


Original Secondary Outcome:

  • Change from baseline in the number of daily bowel movements [ Time Frame: 12 weeks ]
  • Change from baseline in stool consistency [ Time Frame: 12 weeks ]
  • Change from baseline in the number of cutaneous flushing episodes [ Time Frame: 12 weeks ]
  • Change from baseline in abdominal pain [ Time Frame: 12 weeks ]
  • Change in the frequency of rescue short-acting, somatostatin analog used to treat carcinoid syndrome symptoms [ Time Frame: 12 weeks ]
  • Percent change from baseline in 24-hour urinary 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: Week 12 ]


Information By: Lexicon Pharmaceuticals

Dates:
Date Received: February 12, 2014
Date Started: March 11, 2014
Date Completion:
Last Updated: March 31, 2017
Last Verified: March 2017