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

Use our guide to learn which trials are right for you!

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
Ogden, Utah 84405
790
mi
from
Ogden, UT
Click here to add this to my saved trials
Anaheim, California 92801
1155
mi
from
Anaheim, CA
Click here to add this to my saved trials
Great Neck, New York 11021
1301
mi
from
Great Neck, NY
Click here to add this to my saved trials
Little Rock, Arkansas 72211
372
mi
from
Little Rock, AR
Click here to add this to my saved trials
Norman, Oklahoma 73069
176
mi
from
Norman, OK
Click here to add this to my saved trials
San Antonio, Texas 78209
572
mi
from
San Antonio, TX
Click here to add this to my saved trials
Seattle, Washington 98195
1410
mi
from
Seattle, WA
Click here to add this to my saved trials