A Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:7/16/2013
Start Date:December 2011
Contact:Luke Lawson, PhD
Phone:281-863-3146

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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


This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety
and preliminary effectiveness of two blinded dose levels of LX1606 in subjects with acute,
mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
7
sites
Seattle, Washington 98195
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Anaheim, California 92801
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Anaheim, CA
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Great Neck, New York 11021
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Great Neck, NY
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Little Rock, Arkansas 72211
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Little Rock, AR
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Norman, Oklahoma 73069
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Norman, OK
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Ogden, Utah 84405
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Ogden, UT
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San Antonio, Texas 78209
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San Antonio, TX
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