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

Last updated: November 4, 2010
Sponsor: Lexicon Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Colic

Lactose Intolerance

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT00813098
Protocol LX1031.1-201-IBS
LX1031.201
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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-inperiods

  • Normal structural evaluation of the colon within 5 years prior to screening

  • Ability to provide written informed consent

Exclusion

Exclusion Criteria:

  • 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 thataffect bowel motility

  • Lactose intolerance

  • Major psychological disorder

  • Significant nicotine or caffeine use (>10 cigarettes and/or six 8 ounce cups of coffeeper day, respectively)

Study Design

Total Participants: 155
Study Start date:
December 01, 2008
Estimated Completion Date:
August 31, 2010

Connect with a study center

  • Genova Clinical Research

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Arkansas Gastroenterology

    Sherwood, Arkansas 72120
    United States

    Site Not Available

  • Advanced Clinical Research Institute

    Anaheim, California 92801
    United States

    Site Not Available

  • Edinger Medical Group Clinical Research Center

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Impact Clinical Trials

    Los Angeles, California 90036
    United States

    Site Not Available

  • AGMG - Orange

    Orange, California 92869
    United States

    Site Not Available

  • Community Clinical Trials

    Orange, California 92868
    United States

    Site Not Available

  • Medical Associates Research Group

    San Diego, California 92123
    United States

    Site Not Available

  • Lynn Instiute of the Rockies

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Clinical Trials Management of Boca Raton, Inc.

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Consultants for Clinical Research of S. Florida

    Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Research Consultants Group

    Hialeah, Florida 33010
    United States

    Site Not Available

  • Accord Clinical Research, LLC

    Port Orange, Florida 32129
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Northwest Clinical Trials

    Boise, Idaho 83704
    United States

    Site Not Available

  • ActivMed Practice and Research

    Haverhill, Massachusetts 01830
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Affiliated Clinical Research

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Long Island Clinical Research

    Great Neck, New York 11021
    United States

    Site Not Available

  • Cary Medical Research

    Cary, North Carolina 27518
    United States

    Site Not Available

  • The UNC Center for Functional GI & Motility Disorders

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Medoff Medical/Vital re:Search

    Greensboro, North Carolina 27108
    United States

    Site Not Available

  • Unifour Medical Research

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Piedmont Medical Associates

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Consultants for Clinical Research

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Gastroenterology Research Consultant of Greater Cincinnati

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Coastal Carolina Research Center in Goose Creek

    Goose Creek, South Carolina 29455
    United States

    Site Not Available

  • ClinSearch

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Houston Medical Research Associates

    Houston, Texas 77090
    United States

    Site Not Available

  • Pioneer Research Solutions

    Houston, Texas 77036
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden, Utah 84405
    United States

    Site Not Available

  • Utah Clinical Trials, LLC

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • National Clinical Research Norfolk Inc.

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Aurora Health Center - Waukesha

    Waukesha, Wisconsin 53186
    United States

    Site Not Available

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