NCT01456052

A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Telotristat Etiprate	500 mg telotristat etiprate (LX1606) administered orally.
DRUG	Placebo	Matching placebo administered orally.

Timeline

• Start date: 2012-01-30
• Primary completion: 2013-09-03
• Completion: 2013-09-03
• First posted: 2011-10-20
• Last updated: 2019-05-23
• Results posted: 2015-03-11

Locations

24 sites across 4 countries: United States, Lithuania, Poland, Slovakia