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

March 3, 2015 updated by: Lexicon Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
373

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in stool consistency
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in plasma 5-HIAA levels
Time Frame: 4 weeks
4 weeks
Change from baseline in worst abdominal pain in past 24 hours
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lexicon Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sumen Wason, MD, Lexicon Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LX1033.1-201-IBS
  • LX1033.201 (OTHER: Lexicon Pharmaceuticals, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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