At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 59 enrolled
Drug / intervention
Telotristat Etiprate +1 moredrug
Likely dose
Telotristat Etiprate 500 mgfrom 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.
Phase 2 Assessment of the Relationship Between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating Telotristat Etiprate and Placebo for Ulcerative Colitis. Completed, enrolled 59 participants across 24 sites in 4 countries.
Detailed Summary
This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesLithuania, Poland, Slovakia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartJan 2012
Primary CompletionSep 2013
TodayJul 2026
First PostedOct 20, 2011
Enrollment StartJan 30, 2012
Primary CompletionSep 3, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.7 years ago
Interventions
Telotristat Etipratedrug
500 mg telotristat etiprate (LX1606) administered orally.
Placebodrug
Matching placebo administered orally.