A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
NCT ID: NCT01456052
Last Updated: 2019-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2012-01-30
2013-09-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low Dose Telotristat Etiprate
500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
Telotristat Etiprate
500 mg telotristat etiprate (LX1606) administered orally.
High Dose Telotristat Etiprate
500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
Telotristat Etiprate
500 mg telotristat etiprate (LX1606) administered orally.
Placebo
Matching placebo administered orally.
Placebo
Matching placebo administered orally.
Interventions
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Telotristat Etiprate
500 mg telotristat etiprate (LX1606) administered orally.
Placebo
Matching placebo administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Doug Fleming, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Little Rock, Arkansas, United States
Lexicon Investigational Site
Anaheim, California, United States
Lexicon Investigational Site
Santa Monica, California, United States
Lexicon Investigational Site
Great Neck, New York, United States
Lexicon Investigational Site
New York, New York, United States
Lexicon Investigational Site
Tulsa, Oklahoma, United States
Lexicon Investigational Site
Houston, Texas, United States
Lexicon Investigational Site
San Antonio, Texas, United States
Lexicon Investigational Site
Ogden, Utah, United States
Lexicon Investigational Site
Sandy City, Utah, United States
Lexicon Investigational Site
Seattle, Washington, United States
Lexicon Investigational Site
Kaunas, , Lithuania
Lexicon Investigational Site
Klaipėda, , Lithuania
Lexicon Investigational Site
Šiauliai, , Lithuania
Lexicon Investigational Site
Vilnius, , Lithuania
Lexicon Investigational Site
Vilnius, , Lithuania
Lexicon Investigational Site
Krakow, , Poland
Lexicon Investigational Site
Lodz, , Poland
Lexicon Investigational Site
Sopot, , Poland
Lexicon Investigational Site
Warsaw, , Poland
Lexicon Investigational Site
Wroclaw, , Poland
Lexicon Investigational Site
Wroclaw, , Poland
Lexicon Investigational Site
Nitra, , Slovakia
Lexicon Investigational Site
Nové Mesto nad Váhom, , Slovakia
Countries
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Other Identifiers
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LX1606.204
Identifier Type: OTHER
Identifier Source: secondary_id
LX1032
Identifier Type: OTHER
Identifier Source: secondary_id
LX1606.1-204-UC
Identifier Type: -
Identifier Source: org_study_id
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