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

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: 250 mg LX1033 tablets; Drug: Placebo tablet

• Study Type: Interventional
• Enrollment (Actual): 373
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Lexicon Investigational Site
  • Arizona
    • Tempe, Arizona, United States, 85282
      • Lexicon Investigational Site
    • Tucson, Arizona, United States, 85704
      • Lexicon Investigational Site
    • Tucson, Arizona, United States, 85712
      • Lexicon Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Lexicon Investigational Site
    • North Little Rock, Arkansas, United States, 72117
      • Lexicon Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Lexicon Investigational Site
    • Encinitas, California, United States, 92024
      • Lexicon Investigational Site
    • Los Angeles, California, United States, 90095
      • Lexicon Investigational Site
    • Oakland, California, United States, 94609
      • Lexicon Investigational Site
    • Orange, California, United States, 92868
      • Lexicon Investigational Site
    • San Diego, California, United States, 92108
      • Lexicon Investigational Site
    • Santa Monica, California, United States, 90404
      • Lexicon Investigational Site
    • Tustin, California, United States, 92780
      • Lexicon Investigational Site
    • Westlake Village, California, United States, 91361
      • Lexicon Investigational Site
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Lexicon Investigational Site
    • Littleton, Colorado, United States, 80128
      • Lexicon Investigational Site
    • Wheat Ridge, Colorado, United States, 80033
      • Lexicon Investigational Site
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Lexicon Investigational Site
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Lexicon Investigational Site
    • Bradenton, Florida, United States, 34208
      • Lexicon Investigational Site
    • Brooksville, Florida, United States, 34601
      • Lexicon Investigational Site
    • DeLand, Florida, United States, 32720
      • Lexicon Investigational Site
    • Jacksonville, Florida, United States, 32256
      • Lexicon Investigational Site
    • Kissimmee, Florida, United States, 34741
      • Lexicon Investigational Site
    • Lauderdale Lakes, Florida, United States, 33319
      • Lexicon Investigational Site
    • Maitland, Florida, United States, 32751
      • Lexicon Investigational Site
    • Orlando, Florida, United States, 32806
      • Lexicon Investigational Site
    • Port Orange, Florida, United States, 32129
      • Lexicon Investigational Site
    • Tampa, Florida, United States, 33606
      • Lexicon Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83704
      • Lexicon Investigational Site
    • Meridian, Idaho, United States, 83642
      • Lexicon Investigational Site
  • Illinois
    • Addison, Illinois, United States, 60101
      • Lexicon Investigational Site
    • Chicago, Illinois, United States, 60622
      • Lexicon Investigational Site
    • Rockford, Illinois, United States, 61107
      • Lexicon Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Lexicon Investigational Site
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Lexicon Investigational Site
    • Lexington, Kentucky, United States, 40504
      • Lexicon Investigational Site
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Lexicon Investigational Site
    • Towson, Maryland, United States, 21204
      • Lexicon Investigational Site
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Lexicon Investigational Site
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Lexicon Investigational Site
    • Kalamazoo, Michigan, United States, 49009
      • Lexicon Investigational Site
    • Troy, Michigan, United States, 48098
      • Lexicon Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Lexicon Investigational Site
  • Missouri
    • Mexico, Missouri, United States, 65265
      • Lexicon Investigational Site
  • Montana
    • Billings, Montana, United States, 59102
      • Lexicon Investigational Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Lexicon Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Lexicon Investigational Site
  • New York
    • Great Neck, New York, United States, 11021
      • Lexicon Investigational Site
    • Great Neck, New York, United States, 11023
      • Lexicon Investigational Site
    • New York, New York, United States, 10022
      • Lexicon Investigational Site
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • Lexicon Investigational Site
    • Cary, North Carolina, United States, 27518
      • Lexicon Investigational Site
    • Chapel Hill, North Carolina, United States, 27599
      • Lexicon Investigational Site
    • Greensboro, North Carolina, United States, 27408
      • Lexicon Investigational Site
    • High Point, North Carolina, United States, 27262
      • Lexicon Investigational Site
    • Raleigh, North Carolina, United States, 27612
      • Lexicon Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Lexicon Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Lexicon Investigational Site
  • Ohio
    • Kettering, Ohio, United States, 45429
      • Lexicon Investigational Site
    • Lima, Ohio, United States, 45806
      • Lexicon Investigational Site
    • Mentor, Ohio, United States, 44060
      • Lexicon Investigational Site
    • Wadsworth, Ohio, United States, 44281
      • Lexicon Investigational Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Lexicon Investigational Site
    • Oklahoma City, Oklahoma, United States, 73104
      • Lexicon Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97404
      • Lexicon Investigational Site
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Lexicon Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Lexicon Investigational Site
  • Texas
    • Austin, Texas, United States, 78756
      • Lexicon Investigational Site
    • El Paso, Texas, United States, 79902
      • Lexicon Investigational Site
    • Lake Jackson, Texas, United States, 77566
      • Lexicon Investigational Site
    • Plano, Texas, United States, 75075
      • Lexicon Investigational Site
    • San Antonio, Texas, United States, 78229
      • Lexicon Investigational Site
  • Utah
    • Clinton, Utah, United States, 84105
      • Lexicon Investigational Site
    • Logan, Utah, United States, 84341
      • Lexicon Investigational Site
    • Ogden, Utah, United States, 84405
      • Lexicon Investigational Site
    • Sandy, Utah, United States, 84904
      • Lexicon Investigational Site
    • West Jordan, Utah, United States, 84088
      • Lexicon Investigational Site
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Lexicon Investigational Site
    • Virginia Beach, Virginia, United States, 23454
      • Lexicon Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low dose; 500 mg LX1033 two times daily	Drug: 250 mg LX1033 tablets; 250 mg LX1033 tablets administered orally
EXPERIMENTAL: Mid dose; 500 mg LX1033 three times daily	Drug: 250 mg LX1033 tablets; 250 mg LX1033 tablets administered orally
EXPERIMENTAL: High dose; 1000 mg LX1033 two times daily	Drug: 250 mg LX1033 tablets; 250 mg LX1033 tablets administered orally
PLACEBO_COMPARATOR: Placebo; Matching placebo dosing	Drug: Placebo tablet; Matching placebo tablet administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in stool consistency	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in plasma 5-HIAA levels	4 weeks
Change from baseline in worst abdominal pain in past 24 hours	4 weeks

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals
• Investigators: Study Director: Sumen Wason, MD, Lexicon Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Delgado-Herrera L, Lasch K, Zeiher B, Lembo AJ, Drossman DA, Banderas B, Rosa K, Lademacher C, Arbuckle R. Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population. Therap Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (ESTIMATE): December 16, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 23, 2015
• Last Update Submitted That Met QC Criteria: March 3, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: LX1033.1-201-IBS; LX1033.201 (OTHER: Lexicon Pharmaceuticals, Inc.)