A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:11/30/-0001
Start Date:February 2012
Contact:Luke Lawson, Project Manager
Phone:281-863-3146

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A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)


The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of
dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).


Inclusion Criteria:

- Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D)
with symptom onset at least 6 months prior to diagnosis

- Two or more days per week with at least one stool with a consistency of Type 6 or 7
(Bristol Stool Form Scale)

- Weekly average of worst abdominal pain in past 24 hours score of greater than or
equal to 3.0 using a 0-10 point scale

- Ability to provide written, informed consent

Exclusion Criteria:

- Inability to discontinue any current drug therapy for IBS, with the exception of
bulking agents. Subjects will be allowed up to 2 doses of loperamide per week as
rescue medication.

- Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week

- Concomitant use of opioid analgesic drugs or drugs that affect bowel motility

- Any abnormalities or conditions deemed by the investigator as clinically significant
We found this trial at
30
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Albuquerque, New Mexico 87102
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Anaheim, California 92801
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Berlin, New Jersey 08009
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Billings, Montana 59102
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Boise, Idaho 83704
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Boone, North Carolina 28607
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Bowling Green, Kentucky 42101
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Boynton Beach, Florida 33426
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Brockton, Massachusetts 02301
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Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48047
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Chevy Chase, Maryland 20815
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Chicago, Illinois 60622
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Chicago, IL
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Eugene, Oregon 97404
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Fargo, North Dakota 58103
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Great Neck, New York 11021
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Huntsville, Alabama 35801
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Jackson, Mississippi 39202
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Jackson, MS
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Little Rock, Arkansas 72211
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Littleton, Colorado 80128
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Lynchburg, Virginia 24502
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Mentor, Ohio 44060
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Mexico, Missouri 65265
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Mexico, MO
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Mount Pleasant, South Carolina 29464
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Norman, Oklahoma 73069
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Ogden, Utah 84405
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San Antonio, Texas 78209
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Tempe, Arizona 85282
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Waterbury, Connecticut 06708
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Wichita, Kansas 67207
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Wichita, KS
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