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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Ascending, Multidose Study To Determine Safety and Tolerability of Orally Administered LX1606 in Subjects With Symptomatic Carcinoid Syndrome Refractory to Stable-Dose Octreotide Long-Acting Release Depot Therapy
The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.
Details
| Lead sponsor | Lexicon Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 23 |
| Start date | 2009-03 |
| Completion | 2014-06 |
Conditions
- Carcinoid Syndrome
Interventions
- Telotristat etiprate
- Octreotide LAR Depot
- Placebo
Primary outcomes
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase — Up to 4 Weeks Core Phase
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. - Number of Participants With Any TEAE in the Open-Label Extension Phase — Up to 180 weeks in the open-label extension phase
An 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 receiving treatment.
Countries
United States