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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
Telotristat etiprate tablets.
Placebo-matching telotristat etiprate tablets.
Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks
Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Time frame: Baseline and 12 Weeks
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Time frame: First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)
Number of Participants With TEAEs in the Open-Label Extension Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Time frame: First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks)
Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels
u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.
Time frame: Baseline and Week 12
Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points
Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
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Lexicon Investigational Site
Mobile, Alabama, United States
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Palo Alto, California, United States
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San Francisco, California, United States
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Orlando, Florida, United States
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Iowa City, Iowa, United States
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Lexington, Kentucky, United States
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Kenner, Louisiana, United States
Lexicon Investigational Site
Boston, Massachusetts, United States
Lexicon Investigational Site
Boston, Massachusetts, United States
Lexicon Investigational Site
Omaha, Nebraska, United States
...and 65 more locations
Time frame: Baseline and 12 Weeks
Change From Baseline in Abdominal Pain Averaged Across All Time-Points
Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.
Time frame: Baseline and 12 Weeks