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

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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).

Key facts

Study ID

NCT01494233

Run by

Lexicon Pharmaceuticals

People needed

373

Starts

2012-02-01

Last updated by the study team

2015-03-23

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lexicon Investigational Site — Tempe, Arizona, United States
• Lexicon Investigational Site — Tucson, Arizona, United States
• Lexicon Investigational Site — Tucson, Arizona, United States
• Lexicon Investigational Site — Little Rock, Arkansas, United States
• Lexicon Investigational Site — North Little Rock, Arkansas, United States
• Lexicon Investigational Site — Anaheim, California, United States
• Lexicon Investigational Site — Encinitas, California, United States
• Lexicon Investigational Site — Los Angeles, California, United States
• Lexicon Investigational Site — Oakland, California, United States
• Lexicon Investigational Site — Orange, California, United States
• Lexicon Investigational Site — San Diego, California, United States
• Lexicon Investigational Site — Santa Monica, California, United States
• Lexicon Investigational Site — Tustin, California, United States
• Lexicon Investigational Site — Westlake Village, California, United States
• Lexicon Investigational Site — Littleton, Colorado, United States
• Lexicon Investigational Site — Littleton, Colorado, United States
• Lexicon Investigational Site — Wheat Ridge, Colorado, United States
• Lexicon Investigational Site — Waterbury, Connecticut, United States
• Lexicon Investigational Site — Boynton Beach, Florida, United States
• Lexicon Investigational Site — Bradenton, Florida, United States
• Lexicon Investigational Site — Brooksville, Florida, United States
• Lexicon Investigational Site — DeLand, Florida, United States
• Lexicon Investigational Site — Jacksonville, Florida, United States
• Lexicon Investigational Site — Kissimmee, Florida, United States
• Lexicon Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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