Trials / Completed
CompletedNCT01677910
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Lexicon Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Telotristat etiprate | Telotristat etiprate tablets. |
| DRUG | Placebo-matching telotristat etiprate | Placebo-matching telotristat etiprate tablets. |
Timeline
- Start date
- 2013-01-08
- Primary completion
- 2016-03-21
- Completion
- 2016-03-21
- First posted
- 2012-09-03
- Last updated
- 2018-02-27
- Results posted
- 2017-09-18
Locations
75 sites across 12 countries: United States, Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01677910. Inclusion in this directory is not an endorsement.