TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
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 (Clinical Trial)
Actual Enrollment: 135 participants
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were randomized to one of three treatment arms in the double-blind treatment period. After completion of the double-blind treatment period, participants entered an open-label treatment period.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy
Actual Study Start Date: January 8, 2013
Actual Primary Completion Date: March 21, 2016
Actual Study Completion Date: March 21, 2016
- Experimental: 250 mg Telotristat Etiprate
- Experimental: 500 mg Telotristat Etiprate
- Placebo Comparator: Placebo
- Experimental: Telotristat Etiprate Open-Label Extension
- Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome.
|Date last updated at source||2018-04-27|
|Study start date||2013-01-08|
|Estimated primary completion date||2016-03-21|