Status:
COMPLETED
A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Diagnosis of ulcerative colitis of at least 6 months duration
- Disease extends at least 15 cm proximally from the anal verge, documented within the past 3 years
- Flare occurs on 5-aminosalicylic acid (5-ASA)/mesalamine therapy and subject is willing to remain on a stable dose for the duration of the study
- Age ≥18 and \<70 years of age
- Able and willing to provide written informed consent
Exclusion
- Prior terminal ileum or colonic surgery, except appendectomy or hemorrhoid surgery
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
- Clinical signs of fulminant colitis or toxic megacolon
- History of dysplasia associated lesion or mass (DALM)
- Subjects who have had surgery for ulcerative colitis, or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study
- History of primary sclerosing cholangitis
- Any physical or laboratory abnormality deemed by the investigator as clinically significant
- Major surgery within 60 days of Screening
- Use of any investigational agent within 30 days of Screening or any therapeutic protein or antibody within 90 days of Screening
Key Trial Info
Start Date :
January 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2013
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01456052
Start Date
January 30 2012
End Date
September 3 2013
Last Update
May 23 2019
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Lexicon Investigational Site
Little Rock, Arkansas, United States, 72205
2
Lexicon Investigational Site
Anaheim, California, United States, 92801
3
Lexicon Investigational Site
Santa Monica, California, United States, 90404
4
Lexicon Investigational Site
Great Neck, New York, United States, 11021