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 |
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
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