At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 135 enrolled
Drug / intervention
Telotristat etiprate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Telotristat etiprate and Placebo-matching telotristat etiprate for Carcinoid Syndrome. Completed, enrolled 135 participants across 75 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoid Syndrome
CountriesAustralia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartJan 2013
Primary CompletionMar 2016
TodayJul 2026
First PostedSep 3, 2012
Enrollment StartJan 8, 2013
Primary CompletionMar 21, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.8 years ago
Interventions
Telotristat etipratedrug
Telotristat etiprate tablets.
Placebo-matching telotristat etipratedrug
Placebo-matching telotristat etiprate tablets.