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

This study has been completed.
Sponsor:
Information provided by:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00813098
First received: December 19, 2008
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: LX1031 High Dose
Drug: LX1031 Low Dose
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,"In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"


Secondary Outcome Measures:
  • Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
    To assess sensation of urgency to defecate on a daily basis, subjects recorded in their daily diary a response to the following question,"Have you felt or experienced a sense of urgency to pass stool today?" The mean score (proportion of days per week when the subject experienced an urge to defecate) for Week 4 was subtracted from the baseline mean score to determine the mean change from baseline.

  • Change From Baseline at Week 4 in Stool Consistency Scores [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
    Stool consistency was evaluated using the 7-point Bristol Stool Scale in which a score of 1 indicates separate hard lumps, 2 indicates sausage shaped but lumpy, 3 indicates sausage-like with cracks on the surface, 4 indicates sausage-like but smooth and soft, 5 indicates soft blobs with clear cut edges, 6 indicates fluffy pieces with ragged edges, and 7 indicates watery with no solid pieces. The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline.

  • Change From Baseline at Week 4 in Stool Frequency [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
    Subjects recorded the number of times they passed stool on a daily basis in the daily diary. The mean for Week 4 was subtracted from the baseline mean to obtain the mean change from baseline in stool frequency.

  • Change From Baseline at Week 4 on the Severity of Bloating [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
    Subjects recorded in the daily diary the level of bloating they felt on a daily basis using a 100 mm visual analog scale (with 0 being "not at all" and 100 mm being "worst possible"). The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline in severity of bloating.

  • Change From Baseline at Week 4 on the Global Improvement Score. [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
    The IBS Global Improvement Scale (IBS-GAI) asks "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been: 1-substantially worse, 2-moderately worse, 3-slightly worse, 4-no change, 5-slightly improved, 6-moderately improved, 7-substantially improved?" The mean score for Week 4 was subtracted from the mean baseline score to obtain the mean change from baseline on the Global Improvement Score.


Enrollment: 155
Study Start Date: December 2008
Study Completion Date: August 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose
A high dose of LX1031; daily oral intake for 28 days
Drug: LX1031 High Dose
A high dose of LX1031; daily oral intake for 28 days
Experimental: Low Dose
A low dose of LX1031; daily oral intake for 28 days
Drug: LX1031 Low Dose
A low dose of LX1031; daily oral intake for 28 days.
Placebo Comparator: Placebo
Matching placebo dosing with daily oral intake
Drug: Placebo
Matching placebo dosing with daily oral intake

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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-in periods
  • Normal structural evaluation of the colon within 5 years prior to screening
  • Ability to provide written informed consent

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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813098

  Show 36 Study Locations
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Joel P. Freiman, MD Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Joel P. Freiman, MD, MPH / Medical Director Drug Safety, Lexicon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00813098     History of Changes
Other Study ID Numbers: Protocol LX1031.1-201-IBS, LX1031.201
Study First Received: December 19, 2008
Results First Received: October 5, 2010
Last Updated: November 4, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014