Clinical Trial: TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 C
Brief Summary: 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 number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.
Detailed Summary:
Sponsor: Lexicon Pharmaceuticals
Current Primary Outcome:
- Change from baseline in number of daily bowel movements [ Time Frame: Baseline and 12 weeks ]
- Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ]
Original Primary Outcome: Change from baseline in number of daily bowel movements [ Time Frame: 12 weeks ]
Current Secondary Outcome:
- Change from baseline in urinary 5-hydroxyindoleacetic acid (5-HIAA) levels [ Time Frame: Baseline and 12 weeks ]
- Change from baseline in the number of cutaneous flushing episodes [ Time Frame: Baseline and 12 weeks ]
- Change from baseline in abdominal pain [ Time Frame: Baseline and 12 weeks ]
Original Secondary Outcome:
- 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 [ Time Frame: 12 weeks ]
- Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ]
Information By: Lexicon Pharmaceuticals
Dates:
Date Received: August 30, 2012
Date Started: October 2012
Date Completion:
Last Updated: April 7, 2016
Last Verified: April 2016
