MedTrace Logo

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

NCT01456052 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2019-05-23

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Telotristat Etiprate

500 mg telotristat etiprate (LX1606) administered orally.

DRUG

Placebo

Matching placebo administered orally.

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Doug Fleming, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-30
Primary Completion
2013-09-03
Completion
2013-09-03

Countries

  • United States
  • Lithuania
  • Poland
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456052 on ClinicalTrials.gov