Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.

Key facts

Study ID

NCT00813098

Run by

Lexicon Pharmaceuticals

People needed

155

Starts

2008-12-01

Expected to finish

2010-08-01

Last updated by the study team

2010-12-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females aged 18-70 years old
• Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria
• Abdominal pain/discomfort at least 2 days per week during the screening and run-in periods
• Normal structural evaluation of the colon within 5 years prior to screening
• Ability to provide written informed consent

You may not qualify if…

• Inability to discontinue current drug therapy for IBS, except for bulking agents, through the duration of the study
• Use of anticholinergic antidepressants, opioid pain medications, or any drugs that affect bowel motility
• Lactose intolerance
• Major psychological disorder
• Significant nicotine or caffeine use (>10 cigarettes and/or six 8 ounce cups of coffee per day, respectively)

Where it is running

• Genova Clinical Research — Tucson, Arizona, United States
• Arkansas Gastroenterology — Sherwood, Arkansas, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Edinger Medical Group Clinical Research Center — Fountain Valley, California, United States
• Impact Clinical Trials — Los Angeles, California, United States
• Community Clinical Trials — Orange, California, United States
• AGMG - Orange — Orange, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Lynn Instiute of the Rockies — Colorado Springs, Colorado, United States
• Clinical Trials Management of Boca Raton, Inc. — Boca Raton, Florida, United States
• Consultants for Clinical Research of S. Florida — Boynton Beach, Florida, United States
• Research Consultants Group — Hialeah, Florida, United States
• Accord Clinical Research, LLC — Port Orange, Florida, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• ActivMed Practice and Research — Haverhill, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Affiliated Clinical Research — Las Vegas, Nevada, United States
• Long Island Clinical Research — Great Neck, New York, United States
• Cary Medical Research — Cary, North Carolina, United States
• The UNC Center for Functional GI & Motility Disorders — Chapel Hill, North Carolina, United States
• Medoff Medical/Vital re:Search — Greensboro, North Carolina, United States
• Unifour Medical Research — Hickory, North Carolina, United States
• Piedmont Medical Associates — Winston-Salem, North Carolina, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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